Don’t trip up on the diagnosis!

InsideThis Issue...

Featured Lectures ........... 2

Pediatric Transplant ID.... 4

IDea Incubator Competition ................ 10

Microbial Genomics ...... 12

Antimicrobial Stewardship ................ 20

Affiliated Events ............. 26

Virtual Exhibit Hall ......... 31

IDWeek Career Fair ........ 32

Daily NewsThe Official Daily Newspaper of IDWeek 2021

Friday, October 1

Continued on page 28

Don’t trip up on the diagnosis!Get better answers faster.

BFR0001-4902-01

FridayAffiliated Events8 — 8:45 a.m. ETSee page 26.

SHEA Lectureship9 — 9:30 a.m. ETSee page 2.

Stanley A. Plotkin Lecture in Vaccinology Award 9:30 — 10 a.m. ETSee page 2.

Affiliated Events1 — 2:45 p.m. ETSee page 26.

John F. Enders Lecture5:35 — 5:55 p.m. ETSee page 2.

Joseph E. Smadel Lecture 6:25 — 6:55 p.m. ETSee page 2.

As the sun set on Chasing the Sun and rose on IDWeek

proper, the last and first speaker was right at home.

Rochelle Walensky, MD, MPH, may be better known to the public as the director of the Cen-ters for Disease Control and Prevention, but her IDSA and HIVMA ties run deep. She is an IDSA fellow and former IDWeek Program Committee chair, as well as a former HIVMA Board member. But it was her current role as head of CDC — a job that she took in the midst of a global pandemic — that led to her presentation, “Pub-lic Health at Work: CDC and the COVID-19 Response.”

Dr. Rochelle Walensky Shares Successes and Challenges Ahead

Dr. Walensky noted the many charts she looks at daily: case counts, hospitalizations and deaths. While both cases and hospitalizations are declining, deaths — a “lagging indicator,” she said — have plateaued.

Much of that comes from the efficacy of the three vaccines in use in the U.S.: Pfizer/BioNTech, Moderna and Janssen,

which is marketed by Johnson & Johnson. Dr. Walensky said the typical vaccine development process lasts 10 to 15 years, but these three were developed within 10 to 12 months. “How is it that

Rochelle Walensky, MD, MPH, FIDSA

SaturdayCaroline B. Hall Lecture10 —11:15 a.m. ET

Affiliated Events11:30 a.m. — 1:15 p.m. ETSee page 26.

ID Bug Bowl3 —4 p.m. ET

2 • Friday, October 1, 2021 IDWeek Daily News

Four of the premier lectures at IDWeek 2021 serve as a reminder of the challenges

infectious diseases professionals currently face. Whether a virus circulating in an unusual season, developing vaccines at unprece-dented speed or COVID-19 itself, these topics provide ample fodder for thought leaders to share their insight.

But hope is on the way: What we’ve learned through these chal-lenges has the potential to speed up future vaccine development and dramatically reduce infant mortality.

Here is a look at these four groundbreaking talks.

John F. Enders LectureAnn R. Falsey, MD, professor of

medicine at University of Roches-

ter School of Medicine, has spent most of her career exploring RSV in adults, but this summer’s surge was a surprise. It’s usually a winter-time virus. “Because if the pan-demic, everything is off kilter,” she says.

But is RSV in need of a vaccine? Dr. Falsey says, “We’ve spent many years trying to figure out whether

it was a significant enough prob-lem that warranted treatments or vaccines. One of the problems that we’ve had to solve was we didn’t have good diagnostic test. It wasn’t until the development of PCR that we got a good handle on how much disease there was.”

But that does not make an open

Friday’s Lectures Offer Inspiration, Insight


Ann R. Falsey, MD

William C. Gruber, MD

Deborah S. Yokoe, MD

Keith P. Klugman, MD, PhD

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Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure. Assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before the initial infusion of ASCENIV and at appropriate intervals thereafter. Discontinue ASCENIV if renal function deteriorates. In at risk patients, administer ASCENIV at the minimum infusion rate practicable.Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia may occur in patients receiving IGIV treatment, including ASCENIV. It is critical to clinically distinguish true hyponatremia from a pseudohyponatremia that is associated with or causally related to hyperproteinemia. Treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity, and a possible predisposition to thrombotic events.Aseptic meningitis syndrome (AMS) may occur with IGIV treatments, including ASCENIV. AMS usually begins within several hours to 2 days following IGIV treatment. AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV. Conduct a thorough neurological examination on patients exhibiting signs and symptoms of AMS, including cerebrospinal fluid (CSF) studies, to rule out other causes of meningitis.IGIV products, including ASCENIV, may contain blood group antibodies that can act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immunoglobulin, causing a positive direct antiglobulin reaction and hemolysis. Monitor patients for clinical signs and symptoms of hemolysis, including appropriate confirmatory laboratory testing.Non-cardiogenic pulmonary edema may occur with IV administered IG. Monitor patients for pulmonary adverse reactions. If suspected, perform appropriate tests for presence of anti-neutrophil in both product and patient serum. May be managed using oxygen therapy with adequate ventilatory support.Because ASCENIV is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. All infections suspected by a physician to possibly have been transmitted by this product should be reported to ADMA Biologics at (1-800-458-4244).After infusion of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient’s blood may yield positive serological testing results, with the potential for misleading interpretation. Passive transmission of antibodies to erythrocyte antigens (e.g., A, B, and D) may cause a positive direct or indirect antiglobulin (Coombs’) test.Adverse ReactionsThe most common adverse reactions to ASCENIV (≥5% of study subjects) were headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea.You are encouraged to report side effects of prescription drugs to ADMA Biologics @ 1-800-458-4244 or the FDA. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.For additional safety information about ASCENIV, please see full Prescribing Information.

WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILUREThrombosis may occur with immune globulin (IGIV) products, including ASCENIV. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients.Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. ASCENIV does not contain sucrose.For patients at risk of thrombosis, renal dysfunction or renal failure, administer ASCENIVat the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

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Click Here to Register!

Controversies and Challenges in Pediatric Transplant IDFriday, October 12:45 p.m. ET

Transplant patients are a spe-cial population on their own. When that patient is young,

treatment becomes even more complicated.

Those complications are the ba-sis for the session “Controversies and Challenges in Pediatric Trans-plant ID” taking place 2:45 p.m. ET Friday.

“We, as pediatric transplant ID physicians, know our pediatric pa-tients are especially unique,” says Beth Doby Knackstedt, MD, asso-ciate professor, pediatric infectious diseases at the University of Utah. “I hope attendees can appreci-ate the special challenges in best caring for these kids, including optimal dosing and use of antibiot-ics and antifungals to best use of molecular diagnostics.”

Dr. Knackstedt’s presentation, “Empiric and Prophylactic Anti-fungal Therapy in Pediatric Solid Organ Transplant Patients,” will provide plenty of insight into that topic.

“Invasive aspergillosis is the second most common invasive fungal infection in solid organ transplant recipients, but treatment remains challenging especially in pediatric patients,” she says. “We will review currently available an-tifungals used for IA and discuss both new dosage formulations and pediatric PK data, which is allow-ing for increased use in the pediat-ric population. We will also discuss

some of the newest antifungals coming down the pipeline and what data and ongoing trials exist for IA.”

Dosing is of the most chal-lenging aspects of treating pediatric transplant patients. “Pills often aren’t feasible. But certainly the biggest challenge is knowing optimal dosing, both in terms of effectiveness at treating the fungal infection, but also safety,” she says. “Investi-gators are making huge strides in knowing dosing for posacon-azole and isavuconazole, but we know essentially nothing about dosing of the newest antifun-gals in children. If you are deal-ing with a particularly resistant Aspergillus species, knowing how to use these newest anti-fungals, including ibrexafungerp, fosmanogepix and olorofim, is really important.”

In addition to Dr. Knackstedt, Scott Weissman, MD, associate professor at Seattle Children’s Hospital, discusses “Precision Stewardship: Individualized Antibi-otic Plans for Pediatric Transplant Population.” Benjamin Hanisch, MD, assistant professor at Chil-dren’s National Health System, will present “The Impact of Molecular Diagnostics on the Management of Viral Infections in Pediatric Trans-plant Recipients.”

The session is moderated by Hayley Gans, MD, professor at

Stanford University Medical Cen-ter, and Inci Yildirim, MD, PhD, MSc, associate professor of pediatrics (infectious disease) and of public health (epidemiology of microbial diseases), medical direc-tor, transplant infectious diseases and affiliated faculty, Yale Institute for Global Health.

“I am incredibly excited about the other two presenters,” Dr. Knackstedt says. “Our pediatric transplant recipients receive so much antibiotic therapy, both pro-phylactically but also for treatment. And while antibiotics can no doubt be life-saving, they come with their own risks, including altered intes-tinal microbiome and increased risk of drug-resistant organisms. I am excited to hear about how to tailor these strategies to each individual patient to maximize benefit and minimize adverse effects. Molecular diagnostics for viral respiratory infections have been a game changer in pediatrics in general, but I am excited to hear Dr. Hanisch discuss their optimal use, and perhaps even what to do with unexpected positive results, especially pre-transplant.”

The Smaller the Transplant Patient, the Higher the Hurdles

There’s always a way to make life better

Antibiotic treatment is not enoughPatient mortality increases when treated with antibiotics alone.1-3 Heart Rhythm Society guidelines in collaboration with IDSA and others state it is a Class I indication to refer a patient to a lead extractor for consultation with documented CIED infection. Despite that, 72% of patients are not treated in adherence to guidelines.2-4 Delaying lead extraction treatment may have fatal consequence for patient.5

1. Klug, D., et al. (2004). Local symptoms at the site of pacemaker implantation indicate latent systemic infection. Heart, 90(8), 882-886.2. Sohail, M. Rizwan, et al. (2016)“Incidence, Treatment Intensity, and Incremental Annual Expenditures for Patients Experiencing a Cardiac Implantable Electronic Device Infection.” Circulation: Arrhythmia and Electrophysiology 9.8: e003929.3. Philips. (2020b). CIED Infection Treatment Inadequate Adherence to Guidelines. Data on File. 4. Dai, M., et al. (2019) Trends of Cardiovascular Implantable Electronic Device Infection in 3 Decades: A Population-Based Study. JACC Clin Electrophysiol, 5(9), 1071-1080. 5. Kusumoto et al. 2017 HRS Expert Consensus Statement on Cardiovascular Implantable Electronic Device Lead Management and Extraction. Heart Rhythm, 2017.©2021 Koninklijke Philips N.V. All rights reserved. Approved for external distribution. D061171-00 092021

Know the guidelines



“Preparing for Long-Acting Antiretroviral Treatment” Brief Available from HIVMA

In partnership with the National Alliance of State & Territorial AIDS Directors and the American Academy of HIV Medicine, HIVMA maintains an informational brief for clinics and clinicians on “Preparing for Long-Acting Antiretroviral Treatment.”

The brief highlights delivery system, staffing and admin-istrative issues to consider in offering patients access to long-acting injectable antiret-roviral treatment and has been updated with new information on health care coverage, pro-curement and purchasing.

PIDS-IDSA Guideline on Bone Infections in Children Addresses Key Diagnostic and Treatment QuestionsFirst-ever clinical practice guideline includes 14 recommendations on the diagnosis and management of acute hematogenous osteo-myelitis in pediatric patients.

The guideline is intended for all clinicians and health care providers who care for chil-dren with bone infections, including special-ists in pediatric infectious diseases, orthopedics, and emergency care medicine.

Access your copy of the guideline published in the August 2021 Journal of the Pediatric Infectious Diseases Society (JPIDS) at PIDS-IDSA Guideline on Bone Infections in Children.

And hear from 2 of the authors, Drs. Sandra Arnold and Matthew Kronman, discuss and highlight the new guideline on bone infections in children in the special JPIDS podcast available at https://pids.org/podcast/.

A man with a foot lesion in Doha, Qatar. A pregnant woman in Ecuador with an

undulating fever. A U.S. airman with headaches. A farm worker in Para-guay with a fever. These were just some of the challenging cases that were presented to tropical medi-cine experts in Thursday’s session, “Challenging Cases in Travel and Tropical Medicine.”

Laila Woc-Colburn, MD, associ-ate professor, Division of Infectious Diseases, Department of Medicine, Emory University School of Medi-cine, and Heather Yun, MD, deputy commander for medical services and professor of medicine, Uni-formed Services University of the Health Sciences, moderated the session and presented these chal-

Tropical Medicine: Uncovering Clues to Diagnostic Mysteries

lenging cases to a panel who asked for more details, discussed missing information and posited theories as to diagnoses.

It was a lot, Dr. Woc-Coburn said, like real life. “These cases were not known to them before this session,” she said. “These are your true consultants when you call them.”

That concept of asking for help arose several times throughout the discussion. Panelists were Edsel Maurice Salvana, MD, DTM&H, director, Institute of Molecular Biology and Biotechnology Nation-al Institutes of Health, University of the Philippines Manila; Andrea Boggild, MSc, MD, DTMH, FRCPC, medical director, Tropical Disease Unit, Toronto General Hospital and

associate professor, Department of Medicine, University of Toronto; Patrick Hickey, MD, professor and department chair, Pediatrics, Uni-formed Services University of the Health Sciences; and Paola Licht-enberger, MD, associate professor of clinical medicine, infectious diseases/medicine, University of

“Known epidemiology has its limits. We get surprised

all the time, so keep an open mind.”

— Andrea Boggild, MSc, MD, DTMH, FRCPC

https://www.hivma.org/globalassets/hivma/long-acting-arvs-_final-.pdf

https://bit.ly/PIDS-IDSA-2021-Guideline-Bone-Infections

https://pids.org/podcast/

With an estimated 3 million cases each year in the US, cUTI is a leading cause of infection-related hospitalization, with a concerning 52% increase in the incidence of hospital admission for UTI over the course of a decade (1998-2011).2,3,4

Increasing rates of resistance among uropathogens and the rise in hospitalization for UTI suggest that alternative oral options may be necessary for certain patients.4

How can the cUTI treatment approach evolve to meet the challenges of rising pathogen resistance?1

More oral antibiotic options could potentially help to address:

Avoidable hospitalization5 IV-related risks6 Healthcare

utilization costs2

Learn more about cUTI treatment challenges at www.cUTIevolution.comSpero Therapeutics is an emerging leader focused on evolving cUTI management through the identifi cation, development, and

commercialization of novel treatments for gram-negative pathogens to address the most urgent unmet needs of patients.

© 2021 Spero Therapeutics. All Rights Reserved. US-SPR-2100027 09/21

References: 1. Critchley I, Cotroneo N, Pucci M, Mendes R. The burden of antimicrobial resistance among urinary tract isolates of Escherichia coli in the United States in 2017. PLoS ONE. 2019;14(12). doi.org/10.1371/journal.pone.0220265. 2. Carreno J, Tam I, Meyers J, Esterberg E, Candrilli S, Lodise T Jr. Longitudinal, Nationwide, Cohort Study to Assess Incidence, Outcomes, and Costs Associated With Complicated Urinary Tract Infection. Open Forum Infect Dis. 2019. doi:10.1093/ofi d/ofz446. 3. Zilberberg M, Nathanson B, Sulham K, Shorr A. Multiple antimicrobial resistance and outcomes among hospitalized patients with complicated urinary tract infections in the US, 2013-2018: a retrospective cohort study. BMC Infect Dis. 2021;21. doi.org/10.1186/s12879-021-05842-0. 4. Simmering J, Tang F, Cavanaugh J, Polgreen L, Polgreen P. The Increase in Hospitalizations for Urinary Tract Infections and the Associated Costs in the United States, 1998–2011. Open Forum Infec Dis. 2017. doi:10.1093/ofi d/ofw281. 5. Lodise T, Chopra T, Nathanson B, Sulham K. Hospital Admission Patterns of Adult Patients with Complicated Urinary Tract Infections Who Present to the Hospital by Disease Acuity and Comorbid Conditions: How Many Admissions are Potentially Avoidable? Am J Infect Control. 2021;S0196-6553(21)00382-5. doi.org/10.1016/j.ajic.2021.05.013. 6. Thurber K, Arnold J, Narayanan P, Dierkhising R, Sampathkumar P. Comparison of intravenous and oral defi nitive antibiotic regimens in hospitalised patients with Gram-negative bacteraemia from a urinary tract infection. J Globl Antimicrob Resist. 2019;18. doi.org/10.1016/j.jgar.2019.03.013.


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END ENDLESS SEQUELSMicrobiome restoration helps prevent C. diff spore germination—and can change the ending of the same predictable plot1-4

References: 1. McGovern BH, Ford CB, Henn MR, et al. Clin Infect Dis. 2021;72(12):2132-2140. doi:10.1093/cid/ciaa387. 2. Chilton CH, Pickering DS, Freeman J. Clin Microbiol Infect. 2018;24(5):476-482. doi:10.1016/j.cmi.2017.11.017. 3. Isaac S, Scher JU, Djukovic A, et al. J Antimicrob Chemother. 2017;72(1):128-136. doi:10.1093/jac/dkw383. 4. Haak BW, Lankelma JM, Hugenholtz F, Belzer C, de Vos WM, Wiersinga WJ. J Antimicrob Chemother. 2019;74(3):782-786. doi:10.1093/jac/dky471. 5. Kelly CP. Clin Microbiol Infect.2012;18(suppl 6):21-27. doi:10.1111/1469-0691.12046. 6. Budi N, Safdar N, Rose WE. FEMS Microbes. 2020;1(1):1-8. doi:10.1093/femsmc/xtaa001. 7. Lewis BB, Buffie CG, Carter RA, et al. J Infect Dis. 2015;212(10):1656-1665. doi:10.1093/infdis/jiv256. 8. Chang JY, Antonopoulos DA, Kalra A, et al. J Infect Dis. 2008;197(3):435-438. doi:10.1086/525047. 9. Theriot CM, Young VB. Annu Rev Microbiol. 2015;69:445-461. doi:10.1146/annurev-micro-091014-104115. 10. Theriot CM, Bowman AA, Young VB. mSphere.2016;1(1):e00045-15. doi:10.1128/mSphere.00045-15. 11. Gerding DN, Kelly CP, Rahav G, et al. Clin Infect Dis. 2018;67(5):649-656. doi:10.1093/cid/ciy171. 12. Wilcox MH, McGovern BH, Hecht GA. Open Forum Infect Dis. 2020;7(5):1-6. doi:10.1093/ofid/ofaa114.

©Seres Therapeutics, Inc. DA-CDI-US-001-B 9/21

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The Infectious Diseases So-ciety of America and its HIV Medicine Association an-

nounced recipients of the organi-zations’ highest honors during a virtual celebration on Sept. 30.

IDSA is proud to present the Alexander Fleming Lifetime Achievement Award to David Relman, MD, FIDSA. A trailblazing researcher, Dr. Relman developed the first cultivation-independent, molecular approach to identify previously uncharacterized mi-crobes in humans. His work has inspired a revolution in ID mo-lecular diagnostics. A clear voice for ethics, transparency and the public good in the scientific enter-prise, Dr. Relman has contributed to national policy discussions in multiple areas, including gain-of-function research and, most recently, the search for the origins of the SARS-CoV-2 virus.

HIVMA is proud to honor Roger Bedimo, MD, MS, FIDSA, with its Clinical Educator Award, which recognizes members who have demonstrated significant achieve-ment in HIV clinical care and pro-vider education and who move the field of HIV prevention and care. Dr. Bedimo is recognized for his exemplary service contributions as an HIV clinician and researcher, as well as his deep commitment to mentoring the next generation of infectious diseases professionals and increasing equity and access in the field. Most recently, he has taken on four COVID-19 related

national research studies and was selected as a member of the Department of Health and Human Services and National Institutes of Health Panel on Guidelines for the Management of COVID-19.

IDSA and HIVMA are also pleased to recognize the following IDSA and HIVMA members for their outstanding work and contributions to the field:

The D.A. Henderson Award for Outstanding Contributions to Public Health, named to honor the memory of the epidemiologist who led the successful eradication of smallpox, recognizes a lifetime of achievement in public health. This year’s recipient is Lawrence C. Madoff, MD, FIDSA.

The Watanakunakorn Clinician Award honors the memory of Dr. Chatrchai Watanakunakorn and is given by the IDSA Foundation to an IDSA member or fellow in recog-nition of outstanding achievement in the clinical practice of infectious diseases. This year’s awardee is Steven W. Parker, MD, FIDSA.

The Walter E. Stamm Men-tor Award, which honors late past-president Walter E. Stamm, MD, is presented to an IDSA mem-ber or fellow who has been excep-tional in guiding the growth of ID professionals. This year’s winner is Michael Wessels, MD, FIDSA.

The Oswald Avery Award for Early Achievement recognizes outstanding achievement in in-fectious diseases by a member or fellow of IDSA who is 45 or young-er. This year’s recipient is Michail

Lionakis, MD, ScD, FIDSA. The Clinical Practice Innova-

tion Award recognizes members who devote the majority of their time to patient care and who have significantly advanced the clinical practice of infectious diseases within the last 5 years. This year IDSA presents this award to two individuals: Erin K. McCreary, PharmD, BCPS, BCIDP, and Vera Luther, MD, FIDSA.

The Society Citation Award is given in recognition of exemplary contribution to IDSA, an outstand-ing discovery in the field of infec-tious diseases or a lifetime of out-standing achievement. This year, IDSA presents this award to four individuals: Dial Hewlett Jr., MD, FIDSA, Suzanne F. Bradley, MD, FIDSA, Henry Masur, MD, FIDSA, and Tina Tan, MD, FIDSA.

The Clinical Teacher Award honors a career dedicated to teaching clinical infectious diseas-es to fellows, residents and med-ical students, recognizing excel-lence as a clinician and motivation to teach the next generation of physicians. This year, the award goes to Carlos Isada, MD.

The HIVMA Research Award recognizes members who have made significant contributions to HIV clinical or basic research early in their career. This year’s award goes to Colleen Kelley, MD, MPH.

More detailed information and biographical information on award winners is available on the IDSA and HIVMA websites.

IDSA and HIVMA Recognize Members for Outstanding Achievements and Contributions


https://www.idsociety.org/news--publications-new/articles/2021/idsa-recognizes-leading-infectious-diseases-experts/

https://www.hivma.org/news_and_publications/hivma_news_releases/2021/hivma-recognizes-excellence-in-hiv-clinical-education-and-research-with-2021-awards/

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END ENDLESS SEQUELSMicrobiome restoration helps prevent C. diff spore germination—and can change the ending of the same predictable plot1-4

References: 1. McGovern BH, Ford CB, Henn MR, et al. Clin Infect Dis. 2021;72(12):2132-2140. doi:10.1093/cid/ciaa387. 2. Chilton CH, Pickering DS, Freeman J. Clin Microbiol Infect. 2018;24(5):476-482. doi:10.1016/j.cmi.2017.11.017. 3. Isaac S, Scher JU, Djukovic A, et al. J Antimicrob Chemother. 2017;72(1):128-136. doi:10.1093/jac/dkw383. 4. Haak BW, Lankelma JM, Hugenholtz F, Belzer C, de Vos WM, Wiersinga WJ. J Antimicrob Chemother. 2019;74(3):782-786. doi:10.1093/jac/dky471. 5. Kelly CP. Clin Microbiol Infect.2012;18(suppl 6):21-27. doi:10.1111/1469-0691.12046. 6. Budi N, Safdar N, Rose WE. FEMS Microbes. 2020;1(1):1-8. doi:10.1093/femsmc/xtaa001. 7. Lewis BB, Buffie CG, Carter RA, et al. J Infect Dis. 2015;212(10):1656-1665. doi:10.1093/infdis/jiv256. 8. Chang JY, Antonopoulos DA, Kalra A, et al. J Infect Dis. 2008;197(3):435-438. doi:10.1086/525047. 9. Theriot CM, Young VB. Annu Rev Microbiol. 2015;69:445-461. doi:10.1146/annurev-micro-091014-104115. 10. Theriot CM, Bowman AA, Young VB. mSphere.2016;1(1):e00045-15. doi:10.1128/mSphere.00045-15. 11. Gerding DN, Kelly CP, Rahav G, et al. Clin Infect Dis. 2018;67(5):649-656. doi:10.1093/cid/ciy171. 12. Wilcox MH, McGovern BH, Hecht GA. Open Forum Infect Dis. 2020;7(5):1-6. doi:10.1093/ofid/ofaa114.

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The Infectious Diseases Soci-ety of America Foundation, in collaboration with Johnson &

Johnson Innovation – JLABS, re-cently awarded more than $17,000 in funding through the 2021 IDea Incubator competition to three finalists for their promising innova-tions aimed at advancing the field of infectious diseases.

The pitch-style competition was hosted Sept. 28 as a part of the second fully virtual IDWeek conference. The finalists, who were selected out of more than 50 applicants from across the U.S., presented their original ideas, products and concepts to a panel of five judges across the business, technology and health care fields as well as a live virtual audience.

Sanjay Jain, MD, Filipa Mota, PhD, and Alvaro Ordonez, MD, of Johns Hopkins University took home the top grant of $10,000 for their innovation Molecular Imaging of Bacterial Infections. The team developed F-FDS, a patent-pend-ing, bacteria-specific PET imag-ing technology that differentiates Gram-negative bacterial infections from other diseases, such as can-cer metastases and tumors. Unlike more traditional approaches for diagnosing infections, F-FDS does not require surgery or biopsy, has nearly 100% specificity and can detect infections anywhere in the body with rapid results available within the same day.

Kyriaki Hatziagapiou, MD, PhD, Spyridon Kintzios, PhD, and Sofia Mavrikou, PhD, were awarded $5,000 for their innovation Cell-Based Bio-electric Biosensor for the Detection of the SARS-CoV-2 S1 Spike Protein Antigen. The

team developed a low-cost, easy-to-use test that uses bioelectric rec-ognition assay technology to provide a fast and accurate diagnosis of SARS-CoV-2 and other respiratory pathogens, with results provided within three minutes.

Additionally, David Kaufman, MD, and Josh Odrich, both from the University of Virginia, received $2,500 to further develop their innovation, the Neonatal Antibi-otic Stewardship App. The free web-based app offers 24/7 evi-dence-based guidance for neo-natal providers to stop or narrow the spectrum of antibiotics that are prescribed in neonatal inten-sive care units with the hopes of reducing infants’ risks for lifelong adverse effects.

“The IDea Incubator competition sparks innovation and provides funding for exciting new ideas in the field of infectious diseases,” said Stephen E. Peeler, CFRE, executive director of the IDSA Foundation. “Through our con-tinued collaboration with JLABS, we’re able to bring more visibility to this competition among some of the brightest minds across indus-tries, as well as expand the valu-able content offered during the live event.”

This year, by engaging with BLUE KNIGHT™ — JLABS’ joint initiative with BARDA (Biomedical Advanced Research and Devel-opment Authority) — attendees had the opportunity to learn about

Molecular Imaging of Bacterial Infections Awarded Grand Prize at 2021 IDea Incubator Competition

eligibility requirements, selection processes and potential benefits of joining the Blue Knight initia-tive or other BARDA innovation initiatives during an intermission session.

“At the IDea Incubator, we come together to encourage and celebrate big thinkers who are getting creative in their approach to improving global health through science and technology,” said Rachel Rath, MBA, MPH, director of the BARDA Alliance for JLABS. “Through our collaboration with the IDSA Foundation, we can potentially further ignite the work of promising innovators by intro-ducing them to a global network of like-minded experts and entrepre-neurs.”

Javeed Siddiqui, MD, MPH, chair of the IDSA Telehealth and Emerging Technologies Workgroup and co-founder and chief medical officer of TeleMed2U, launched the first IDea Incubator at IDWeek in 2018. Since then, the competi-tion has awarded nearly $70,000 in funding. Siddiqui served as the host of this year’s competition.

For more information about IDea Incubator, including infor-mation about past awardees, visit idsafoundation.org/ideaincubator.

A full recording of this year’s competition is also available.

(left to right) Alvaro Ordonez, MD, Filipa Mota, PhD, and Sanjay Jain, MD

https://idsafoundation.org/

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https://societycentral.zoom.us/webinar/register/8416300877736/WN_Q1Qsa4KgSri0CBjKqaiKJA

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Our commitment to infectious diseases control

Presentation Theater“Antimicrobial Resistance: A Patient Perspective”

This presentation theater will focus on the challenges faced by patients when encountering antimicrobial resistance. The expert panel will review patient experience from across infectious disease where AMR is high; HIV, Tuberculosis and Urinary tract infections. The panel will focus on the scientific, clinical and policy changes needed to support patients in advocating for better education and understanding of AMR.

Thursday, Sept 23rd / 11am - 12pm EST

Speaker Names:– Dr. Ravina Kullar, PharmD, MPH, FIDSA

ID specialist– James Anderson, Executive Director of

Global Health IFPMA

Learning Lounge“From Transmission to Viral Replication and Response - Managing Early COVID-19 in High-Risk Cases”

This learning lounge will broadly outline the current state of the pandemic: both on a national level and in terms of our understanding of the disease. Dr. Griffin will explain the early stages of COVID-19 disease and the appropriate timing of interventions, particularly in high-risk groups. He will discuss the impact of emerging variants and the vaccination program on managing COVID-19. Lastly, Dr. Griffin will discuss emerging opportunities and challenges in managing COVID-19.

Friday, Oct 1st / 1pm - 1:45pm EST

Speaker Name:– Dr. Daniel Griffin, MD, PhD, CTropMed

CTH, Chief of Division of InfectiousDisease - ProHealth

Learning Lounge“Manifestations of COVID-19 Disease: From Viral Response to Immune-Driven Disease”

This learning lounge will discuss current practices in the management of severe/critical COVID-19 in a hospital setting, highlighting the important role of hyper inflammation in progression to severe/critical COVID-19 disease. Dr. Nguyen will emphasize the significance of age and co-morbidities in progression to severe/critical COVID-19 and discuss the developments, challenges, and opportunities of managing COVID-19 in the context of the vaccination programs. Finally he will update attendees on the impact of new SARS-CoV-2 variants on the prevalence and management of severe COVID-19.

Thursday, Sept 30th / 2pm - 2:45pm EST

Speaker Names: – Dr. Bryant Nguyen, MD

Head of Division of Pulmonary Critical Care,Hyperbaric, Allergy and Sleep Medicine atLoma Linda University Health

– Dr. Patrick Taylor, MDMedical Director USMA COVIDTherapeutics, GSKPresident & CEO York Hospital, Maine

Learning Lounge“Adolescent and adult immunizations during and after COVID-19”

This learning lounge will summarize the challenges and opportunities related to the suboptimal immunization rates in adolescents and adults before and during the COVID-19 pandemic, the impact of the COVID-19 pandemic on the routinely recommended vaccines uptake in these populations, the importance of vaccines as a key public health intervention to help achieve healthy ageing and a quick review of the strategies required to increase confidence in vaccines.

Friday, Oct 1st / 2pm - 2:45pm

Speaker Names:– Iriny Salib, Pharm D; Leah Smith,

PharmD, BCPS, BCGP; Luis Romano,MD; Sara Poston, PharmD; ScottPreiss, PhD; Tiffany Mond, PharmD

– Speakers are part of GSK Medical AffairsTeam

Learning Lounge“Antibiotic resistance (AMR) in uncomplicated UTI in the community: Does it exist? Does it matter?”

Over the last decade, community acquired resistance to antimicrobials has increased dramatically, with uncomplicated urinary tract infections (uUTIs) being one of the most prevalent in the community.In this Learning Lounge Professors Keith Kaye and Jason Pogue will review antibiotic resistance in the community in light of recently published data on the outcomes relating to AMR in uUTIs. The panel will review the impact of continuing with empirical treatment against successful examples of stewardship in the community.

Thursday, Sept 30th / 3pm - 3:45pm EST

Speaker Names:– Dr. Keith S. Kaye, MD, MPH

Professor of Infectious Diseases, MDUniversity of Michigan, USA

– Dr. Jason Pogue, PharmD, BCPS,BCIDP Professor Department ofClinical Pharmacy - University ofMichigan, USA

Have you missed one of our Affiliated Programs sessions? They are available on demand!©2021 GSK group of companies or its licensor. All events are intended for HCPs, to support disease state education. Sponsored by GSK. PSE-US-0393 | September 2021

Come and Learn more about our science at our GSK virtual medical booth

Today Friday Oct 1st: Learning Lounges on managing early COVID-19 in high risk cases and immunizations in COVID-19 era

https://2021v1.gskmedicalcongresshub.com/

Come and Learn more about our science at our GSK virtual medical booth


THE MORE YOU DETECTTHE BETTER YOU PROTECTImprove care for more patients with ePlex® Blood Culture Identifi cation Panels, the only BCID panels that can detect >95% of organisms that cause sepsis

To learn more, scan or visit GenMarkDX.com/DetectMore

• Rapid, actionable results on all shifts. Save days compared to conventional blood culture-based methods for improved time to targeted therapy and reduced hospital length of stay.

• Support antimicrobial stewardship. Begin appropriate therapy sooner with broad resistance gene coverage while reducing use of broad spectrum antimicrobials.

While the COVID-19 pan-demic has had a high cost, it also has brought a

better understanding of microbial genomics.

“Really before COVID-19, we were on the verge of using patho-gen sequencing in hospitals,” says Sharon Peacock, MRCP, MRC-Path, PhD, professor of public health and microbiology at the University of Cambridge. “When COVID-19 came along, it was a revolution for pathogen sequenc-ing. The whole discipline began to see how valuable it is. The key thing is using the opportunity that we’ve been given through the strategy of SARS-CoV-2 and leap-ing into that space without delay.”

Microbial Genomics: Ready for Prime Time?Friday, October 110 a.m. ET

Dr. Peacock discusses where this goes next in “Transforming the Translation of Pathogen Se-quencing into Practice in the Wake of COVID-19.” It is part of a larger session, “Microbial Genomics: Ready for Prime Time?”

Gautam Dantas, PhD, professor at Washington University School of Medicine in St. Louis, takes on the topic of “Sequence- and Func-tion-Based Methods and Resourc-es to Study Antimicrobial Resis-tance.” Anne-Catrin Uhlemann, MD, PhD, associate professor at Columbia University Irving Medical Center, and Michael Glickman, MD, FIDSA, FAAM, member and attending physician at Memorial Sloan Kettering, moderate the ses-

Microbial Genomics Takes Its Turn in the Spotlight

sion, which is at 10 a.m. ET Friday. Dr. Peacock frames her talk in

the form of questions, including asking about the best location to perform sequencing: “It’s been debated for a year, whether this should occur in centralized in labs or distributed across the country. I land on the idea that we should do hub and spoke sequencing. Many people can do sequencing,


The American Society for Microbiology (ASM) advances the microbial sciences by publishing top-quality research that is highly cited and read worldwide.

Join 1 million+ authors who publish with ASM

MAY 2021, VOLUME 95, NUMBER 10

Journal ofVirology

Published

Twice Monthly

by the

AmericanSociety forMicrobiology

JVI

Publish with the American Society for Microbiology

June 2021Volume 203Number 12Published Twice Monthly

Journal of Bacteriology

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© 2021 Shionogi Inc. Florham Park, NJ 07932. All Rights Reserved.Fetroja is a registered trademark of Shionogi & Co., Ltd. Osaka, Japan. USFET-0349 05/21

In HABP/VABP and cUTI caused by susceptible Gram-negative microorganisms

OUTSMART RESISTANCEFetroja outsmarts pathogens by using iron to

gain cell entry, like a Trojan horse.1,2

References: 1. Fetroja (cefiderocol) [package insert]. Florham Park, NJ: Shionogi Inc.; 2020. 2. Zhanel GG, Golden AR, Zelenistky S, et al. Cefiderocol: a siderophore cephalosporin with activity against carbapenem-resistant and multidrug-resistant Gram-negative bacilli. Drugs. 2019;79(3):271-289. 3. Iregui A, Khan Z, Landman D, Quale J. Activity of cefiderocol against Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter baumannii endemic to medical centers in New York City. Microb Drug Resist. 2020;26(7):1-5. 4. Iregui A, Khan Z, Landman D, Quale J. Activity of cefiderocol against Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter baumannii endemic to medical centers in New York City. Microb Drug Resist. 2020;26(7) (suppl):S1-S3. 5. Data on file. 6. Brooke JS. Stenotrophomonas maltophilia: an emerging global opportunistic pathogen. Clin Microbiol Rev. 2012;25(1):2-41. 7. Ruppé É, Woerther PL, Barbier F. Mechanisms of antimicrobial resistance in Gram- negative bacilli. Ann Intensive Care. 2015;5(1):61. doi:10.1186/s13613-015-0061-0. 8. Adeolu M, Alnajar S, Naushad S, Gupta RS. Genome-based phylogeny and taxonomy of the 'Enterobacteriales': proposal for Enterobacterales ord. nov. divided into the families Enterobacteriaceae, Erwiniaceae fam. nov., Pectobacteriaceae fam. nov., Yersiniaceae fam. nov., Hafniaceae fam. nov., Morganellaceae fam. nov., and Budviciaceae fam. nov. Int J Syst Evol Microbiol. 2016;66(12):5575-5599.

INDICATIONSFetroja® (cefiderocol) is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex.Fetroja is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens.USAGETo reduce the development of drug-resistant bacteria and maintain the effectiveness of Fetroja and other antibacterial drugs, Fetroja should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONSFetroja is contraindicated in patients with a known history of severe hypersensitivity to cefiderocol or other beta-lactam antibacterial drugs, or any other component of Fetroja.WARNINGS AND PRECAUTIONSIncrease in All-Cause Mortality in Patients with Carbapenem- Resistant Gram-Negative Bacterial Infections An increase in all-cause mortality was observed in patients treated with Fetroja as compared to best available therapy (BAT) in a multinational, randomized, open-label trial in critically ill patients with carbapenem-resistant Gram-negative bacterial infections (NCT02714595). Patients with nosocomial pneumonia, bloodstream infections, sepsis, or cUTI were included in the trial. BAT regimens varied according to local practices and consisted of 1 to 3 antibacterial drugs with activity against Gram-negative bacteria. Most of the BAT regimens contained colistin.

The increase in all-cause mortality occurred in patients treated for nosocomial pneumonia, bloodstream infections, or sepsis. The 28-Day all-cause mortality was higher in patients treated with Fetroja than in patients treated with BAT [25/101 (24.8%) vs 9/49 (18.4%), treatment difference 6.4%, 95% CI (-8.6, 19.2)]. All-cause mortality remained higher in patients treated with Fetroja than in patients treated with BAT through Day 49 [34/101 (33.7%) vs 10/49 (20.4%), treatment difference 13.3%, 95% CI (-2.5, 26.9)]. Generally, deaths were in patients with infections caused by Gram-negative organisms, including non-fermenters such as Acinetobacter baumannii complex, Stenotrophomonas maltophilia, and Pseudomonas aeruginosa, and were the result of worsening or complications of infection, or underlying comorbidities. The cause of the increase in mortality has not been established.Closely monitor the clinical response to therapy in patients with cUTI and HABP/VABP.Hypersensitivity ReactionsSerious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Hypersensitivity was observed in Fetroja-treated patients in clinical trials. These reactions are more likely to occur in individuals with a history of beta-lactam hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Please see a Brief Summary of Prescribing Information on following page.

Seizures and Other Central Nervous System (CNS) Adverse ReactionsCephalosporins, including Fetroja, have been implicated in triggering seizures. Nonconvulsive status epilepticus (NCSE), encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia have been reported with cephalosporins particularly in patients with a history of epilepsy and/or when recommended dosages of cephalosporins were exceeded due to renal impairment. Adjust Fetroja dosing based on creatinine clearance. Anticonvulsant therapy should be continued in patients with known seizure disorders. If CNS adverse reactions including seizures occur, patients should undergo a neurological evaluation to determine whether Fetroja should be discontinued.Development of Drug-Resistant Bacteria Prescribing Fetroja in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.ADVERSE REACTIONSThe most common adverse reactions occurring in (≥2%) of patients receiving Fetroja compared to imipenem/cilastatin in the cUTI trial were: diarrhea (4% vs 6%), infusion site reactions (4% vs 5%), constipation (3% vs 4%), rash (3% vs <1%), candidiasis (2% vs 3%), cough (2% vs <1%), elevations in liver tests (2% vs <1%), headache (2% vs 5%), hypokalemia (2% vs 3%), nausea (2% vs 4%), and vomiting (2% vs 1%). The most common adverse reactions occurring in (≥4%) of patients receiving Fetroja compared to meropenem in the HABP/VABP trial were: elevations in liver tests (16% vs 16%), hypokalemia (11% vs 15%), diarrhea (9% vs 9%), hypomagnesemia (5% vs <1%), and atrial fibrillation (5% vs 3%).

TREATMENT FOR NOSOCOMIAL PNEUMONIA HAS ARRIVED

FOR MORE INFORMATION, VISITFetrojaID.com

IMPORTANT SAFETY INFORMATION (continued) WARNINGS AND PRECAUTIONS (continued) Hypersensitivity Reactions (continued) Before therapy with Fetroja is instituted, inquire about previous hypersensitivity reactions to cephalosporins, penicillins, or other beta-lactam antibacterial drugs. Discontinue Fetroja if an allergic reaction occurs. Clostridioides difficile-associated Diarrhea (CDAD)Clostridioides difficile-associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial agents, including Fetroja. CDAD may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of C. difficile.Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents.If CDAD is suspected or confirmed, antibacterial drugs not directed against C. difficile may need to be discontinued. Manage fluid and electrolyte levels as appropriate, supplement protein intake, monitor antibacterial treatment of C. difficile, and institute surgical evaluation as clinically indicated.

Fetroja—the world’s only siderophore cephalosporin—overcomes Gram-negative antibacterial resistance1

Stable in vitro against all known classes of ϐ-lactamases, including serine-carbapenemases (such as KPC and OXA) and metallo-ϐ-lactamases (such as VIM, IMP, and NDM)1

Active against pathogens with porin channel deletions and efflux pump up-regulation1,3,4

Fetroja is highly active in vitro vs Gram-negative carbapenem-NS pathogens5

In this study, susceptibility of >38,000 Gram-negative clinical isolates from multiple countries (2013-2018) was tested against Fetroja

In a seriously ill patient population with HABP or VABP, Fetroja exhibited non-inferiority to extended-infusion, high-dose meropenem1

Study Design Multicenter, double-blind, parallel-group, randomized, active-controlled Phase 3 study in approximately 300 adults with nosocomial pneumonia caused by Gram-negative bacteria. Subjects were randomized (1:1) to either cefiderocol, 2 grams, administered IV over 3 hours every 8 hours (q8h) or extended-infusion, high-dose meropenem, 2 grams, administered IV over 3 hours q8h. Randomization was performed by the stratified randomization method using their infection diagnosis (HABP, VABP, and HCABP) and Acute Physiology And Chronic Health Evaluation II (APACHE II) score (≤15 and ≥16) as allocation factors. Linezolid was administered for at least 5 days to subjects in both arms to provide coverage for methicillin-resistant Staphylococcus aureus (MRSA), and to maintain the study blind.1,5

In vitro susceptibility study design Clinical isolates of Gram-negative bacteria were collected from 4 global surveillance studies (SIDERO-WT-2014, SIDERO-WT-2015, SIDERO-WT-2016, and SIDERO-WT-2018) that included Enterobacterales* and non-fermenter strains. The global surveillance study (Proteeae†) collected clinical isolates from 2013-2016, and were tested centrally (IHMA Inc., Schaumburg, IL, USA). Fetroja MICs were determined by microbroth dilution using iron-depleted cation-adjusted Mueller-Hinton broth (ID-CAMHB) as approved by the Clinical and Laboratory Standards Institute (CLSI) subcommittee on antimicrobial susceptibility testing in January 2016. FDA breakpoints were used for Enterobacterales MIC ≤4 μg/mL, P aeruginosa MIC ≤1 μg/mL, and A baumannii complex‡ MIC ≤1 μg/mL, whereas CLSI investigational breakpoint was used for S maltophilia MIC ≤4 μg/mL. Carbapenem-non-susceptible strain was defined as meropenem MIC ≥2 μg/mL for Enterobacterales strains (including Proteeae) and MIC ≥4 μg/mL for P aeruginosa and A baumannii complex.5

a FDA breakpoints used for Enterobacterales MIC ≤4 μg/mL, P aeruginosa MIC ≤1 μg/mL, and A baumannii complex MIC ≤1 μg/mL.

b CLSI investigational breakpoint used for S maltophilia MIC ≤4 μg/mL.* E coli, K pneumoniae, other Klebsiella spp, Enterobacter spp, Serratia spp, and Citrobacter spp.

† Morganella morganii, P mirabilis, Proteus vulgaris, and Providencia rettgeri.‡ A baumannii complex consists of A baumannii, A calcoaceticus, A dijkshoorniae, A nosocomialis, A pittii, and A seifertii.

*Also included in cUTI indication.

In vitro activity does not necessarily correlate with clinical efficacy.

Fetroja has an extensive Gram-negative spectrum that includes hard-to-treat pathogens1 Fetroja has demonstrated activity against the following Gram-negative bacteria, both in vitro and in HABP/VABP:Acinetobacter baumannii complex, Escherichia coli*, Enterobacter cloacae complex*, Klebsiella pneumoniae*, Pseudomonas aeruginosa*, Serratia marcescens

• Study highlights: – Meropenem was used as a comparator in the trial and was

optimized (2 grams IV over 3 h q8h) for seriously ill patients with a multidrug-resistant Gram-negative infection in the ICU1

– 60% of patients were ventilated, while approximately 33% had failed empiric treatment1,5

– The top 5 baseline Gram-negative pathogens were K pneumoniae, P aeruginosa, A baumannii, E coli, and E cloacae5

• At Day 14, all-cause mortality (primary endpoint) in the mITT population was 12.4% for Fetroja vs 12.2% for extended-infusion, high-dose meropenem (95% CI, -7.2, 7.7)1

• Fetroja exhibited comparable safety vs extended-infusion, high-dose meropenem in HABP/VABP1

0 20 40 60 80 100

PERCENT

Overall

Overall

Overall

Overall

carbapenem-non-susceptible



100%

100%

98%

90%

97%

95%

85%

(n=25,995)

(n=6213)

(n=814)

(n=1416)

(n=4185)

(n=1565)

(n=2274)

Enterobacteralesa

P aeruginosaa

Enterobacteralesa

P aeruginosaa

A baumannii complexa

S maltophiliab


(inherently carbapenem-resistant)5,7

In a phylogenetic reclassification performed in 2016, the nomenclature of Enterobacterales was proposed, which includes formerly established Enterobacteriaceae family and other genera such as Proteus spp, Providencia spp, Photorhabdus spp, and Serratia spp.8

CI=confidence interval.

S:15"

S:10.5"

T:17"

T:11"

B:17.25"

B:11.25"





Job info

Team


DIN Pro (Regular, Cond Bold, Cond Medium, Bold, Italic, Bold Italic, Medium, Medium Italic, Cond, Cond Italic), Symbol Std (Medium), Futura Std (Medium)

Fonts Images

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SHIO_A073704_RGB.tif (RGB; 654 ppi; 11%; 70.9MB), Shionogi_RGB.eps (5.95%; 750KB), US_Fetroja_Logo_RGB.eps (64.11%; 574KB), Fetroja_Bullets_FNL_RV2 _RGB.eps (49.92%; 520KB), CVA_Fetroja susceptible Chart_AD_M RGB.ai (44%; 133KB)

Scale: 1" = 1"




_ _

© 2021 Shionogi Inc. Florham Park, NJ 07932. All Rights Reserved.Fetroja is a registered trademark of Shionogi & Co., Ltd. Osaka, Japan. USFET-0349 05/21

In HABP/VABP and cUTI caused by susceptible Gram-negative microorganisms

OUTSMART RESISTANCEFetroja outsmarts pathogens by using iron to

gain cell entry, like a Trojan horse.1,2

References: 1. Fetroja (cefiderocol) [package insert]. Florham Park, NJ: Shionogi Inc.; 2020. 2. Zhanel GG, Golden AR, Zelenistky S, et al. Cefiderocol: a siderophore cephalosporin with activity against carbapenem-resistant and multidrug-resistant Gram-negative bacilli. Drugs. 2019;79(3):271-289. 3. Iregui A, Khan Z, Landman D, Quale J. Activity of cefiderocol against Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter baumannii endemic to medical centers in New York City. Microb Drug Resist. 2020;26(7):1-5. 4. Iregui A, Khan Z, Landman D, Quale J. Activity of cefiderocol against Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter baumannii endemic to medical centers in New York City. Microb Drug Resist. 2020;26(7) (suppl):S1-S3. 5. Data on file. 6. Brooke JS. Stenotrophomonas maltophilia: an emerging global opportunistic pathogen. Clin Microbiol Rev. 2012;25(1):2-41. 7. Ruppé É, Woerther PL, Barbier F. Mechanisms of antimicrobial resistance in Gram- negative bacilli. Ann Intensive Care. 2015;5(1):61. doi:10.1186/s13613-015-0061-0. 8. Adeolu M, Alnajar S, Naushad S, Gupta RS. Genome-based phylogeny and taxonomy of the 'Enterobacteriales': proposal for Enterobacterales ord. nov. divided into the families Enterobacteriaceae, Erwiniaceae fam. nov., Pectobacteriaceae fam. nov., Yersiniaceae fam. nov., Hafniaceae fam. nov., Morganellaceae fam. nov., and Budviciaceae fam. nov. Int J Syst Evol Microbiol. 2016;66(12):5575-5599.

INDICATIONSFetroja® (cefiderocol) is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex.Fetroja is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens.USAGETo reduce the development of drug-resistant bacteria and maintain the effectiveness of Fetroja and other antibacterial drugs, Fetroja should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONSFetroja is contraindicated in patients with a known history of severe hypersensitivity to cefiderocol or other beta-lactam antibacterial drugs, or any other component of Fetroja.WARNINGS AND PRECAUTIONSIncrease in All-Cause Mortality in Patients with Carbapenem- Resistant Gram-Negative Bacterial Infections An increase in all-cause mortality was observed in patients treated with Fetroja as compared to best available therapy (BAT) in a multinational, randomized, open-label trial in critically ill patients with carbapenem-resistant Gram-negative bacterial infections (NCT02714595). Patients with nosocomial pneumonia, bloodstream infections, sepsis, or cUTI were included in the trial. BAT regimens varied according to local practices and consisted of 1 to 3 antibacterial drugs with activity against Gram-negative bacteria. Most of the BAT regimens contained colistin.

The increase in all-cause mortality occurred in patients treated for nosocomial pneumonia, bloodstream infections, or sepsis. The 28-Day all-cause mortality was higher in patients treated with Fetroja than in patients treated with BAT [25/101 (24.8%) vs 9/49 (18.4%), treatment difference 6.4%, 95% CI (-8.6, 19.2)]. All-cause mortality remained higher in patients treated with Fetroja than in patients treated with BAT through Day 49 [34/101 (33.7%) vs 10/49 (20.4%), treatment difference 13.3%, 95% CI (-2.5, 26.9)]. Generally, deaths were in patients with infections caused by Gram-negative organisms, including non-fermenters such as Acinetobacter baumannii complex, Stenotrophomonas maltophilia, and Pseudomonas aeruginosa, and were the result of worsening or complications of infection, or underlying comorbidities. The cause of the increase in mortality has not been established.Closely monitor the clinical response to therapy in patients with cUTI and HABP/VABP.Hypersensitivity ReactionsSerious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Hypersensitivity was observed in Fetroja-treated patients in clinical trials. These reactions are more likely to occur in individuals with a history of beta-lactam hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Please see a Brief Summary of Prescribing Information on following page.

Seizures and Other Central Nervous System (CNS) Adverse ReactionsCephalosporins, including Fetroja, have been implicated in triggering seizures. Nonconvulsive status epilepticus (NCSE), encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia have been reported with cephalosporins particularly in patients with a history of epilepsy and/or when recommended dosages of cephalosporins were exceeded due to renal impairment. Adjust Fetroja dosing based on creatinine clearance. Anticonvulsant therapy should be continued in patients with known seizure disorders. If CNS adverse reactions including seizures occur, patients should undergo a neurological evaluation to determine whether Fetroja should be discontinued.Development of Drug-Resistant Bacteria Prescribing Fetroja in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.ADVERSE REACTIONSThe most common adverse reactions occurring in (≥2%) of patients receiving Fetroja compared to imipenem/cilastatin in the cUTI trial were: diarrhea (4% vs 6%), infusion site reactions (4% vs 5%), constipation (3% vs 4%), rash (3% vs <1%), candidiasis (2% vs 3%), cough (2% vs <1%), elevations in liver tests (2% vs <1%), headache (2% vs 5%), hypokalemia (2% vs 3%), nausea (2% vs 4%), and vomiting (2% vs 1%). The most common adverse reactions occurring in (≥4%) of patients receiving Fetroja compared to meropenem in the HABP/VABP trial were: elevations in liver tests (16% vs 16%), hypokalemia (11% vs 15%), diarrhea (9% vs 9%), hypomagnesemia (5% vs <1%), and atrial fibrillation (5% vs 3%).

TREATMENT FOR NOSOCOMIAL PNEUMONIA HAS ARRIVED

FOR MORE INFORMATION, VISITFetrojaID.com

IMPORTANT SAFETY INFORMATION (continued) WARNINGS AND PRECAUTIONS (continued) Hypersensitivity Reactions (continued) Before therapy with Fetroja is instituted, inquire about previous hypersensitivity reactions to cephalosporins, penicillins, or other beta-lactam antibacterial drugs. Discontinue Fetroja if an allergic reaction occurs. Clostridioides difficile-associated Diarrhea (CDAD)Clostridioides difficile-associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial agents, including Fetroja. CDAD may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of C. difficile.Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents.If CDAD is suspected or confirmed, antibacterial drugs not directed against C. difficile may need to be discontinued. Manage fluid and electrolyte levels as appropriate, supplement protein intake, monitor antibacterial treatment of C. difficile, and institute surgical evaluation as clinically indicated.

Fetroja—the world’s only siderophore cephalosporin—overcomes Gram-negative antibacterial resistance1

Stable in vitro against all known classes of ϐ-lactamases, including serine-carbapenemases (such as KPC and OXA) and metallo-ϐ-lactamases (such as VIM, IMP, and NDM)1

Active against pathogens with porin channel deletions and efflux pump up-regulation1,3,4

Fetroja is highly active in vitro vs Gram-negative carbapenem-NS pathogens5

In this study, susceptibility of >38,000 Gram-negative clinical isolates from multiple countries (2013-2018) was tested against Fetroja

In a seriously ill patient population with HABP or VABP, Fetroja exhibited non-inferiority to extended-infusion, high-dose meropenem1

Study Design Multicenter, double-blind, parallel-group, randomized, active-controlled Phase 3 study in approximately 300 adults with nosocomial pneumonia caused by Gram-negative bacteria. Subjects were randomized (1:1) to either cefiderocol, 2 grams, administered IV over 3 hours every 8 hours (q8h) or extended-infusion, high-dose meropenem, 2 grams, administered IV over 3 hours q8h. Randomization was performed by the stratified randomization method using their infection diagnosis (HABP, VABP, and HCABP) and Acute Physiology And Chronic Health Evaluation II (APACHE II) score (≤15 and ≥16) as allocation factors. Linezolid was administered for at least 5 days to subjects in both arms to provide coverage for methicillin-resistant Staphylococcus aureus (MRSA), and to maintain the study blind.1,5

In vitro susceptibility study design Clinical isolates of Gram-negative bacteria were collected from 4 global surveillance studies (SIDERO-WT-2014, SIDERO-WT-2015, SIDERO-WT-2016, and SIDERO-WT-2018) that included Enterobacterales* and non-fermenter strains. The global surveillance study (Proteeae†) collected clinical isolates from 2013-2016, and were tested centrally (IHMA Inc., Schaumburg, IL, USA). Fetroja MICs were determined by microbroth dilution using iron-depleted cation-adjusted Mueller-Hinton broth (ID-CAMHB) as approved by the Clinical and Laboratory Standards Institute (CLSI) subcommittee on antimicrobial susceptibility testing in January 2016. FDA breakpoints were used for Enterobacterales MIC ≤4 μg/mL, P aeruginosa MIC ≤1 μg/mL, and A baumannii complex‡ MIC ≤1 μg/mL, whereas CLSI investigational breakpoint was used for S maltophilia MIC ≤4 μg/mL. Carbapenem-non-susceptible strain was defined as meropenem MIC ≥2 μg/mL for Enterobacterales strains (including Proteeae) and MIC ≥4 μg/mL for P aeruginosa and A baumannii complex.5

a FDA breakpoints used for Enterobacterales MIC ≤4 μg/mL, P aeruginosa MIC ≤1 μg/mL, and A baumannii complex MIC ≤1 μg/mL.

b CLSI investigational breakpoint used for S maltophilia MIC ≤4 μg/mL.* E coli, K pneumoniae, other Klebsiella spp, Enterobacter spp, Serratia spp, and Citrobacter spp.

† Morganella morganii, P mirabilis, Proteus vulgaris, and Providencia rettgeri.‡ A baumannii complex consists of A baumannii, A calcoaceticus, A dijkshoorniae, A nosocomialis, A pittii, and A seifertii.

*Also included in cUTI indication.

In vitro activity does not necessarily correlate with clinical efficacy.

Fetroja has an extensive Gram-negative spectrum that includes hard-to-treat pathogens1 Fetroja has demonstrated activity against the following Gram-negative bacteria, both in vitro and in HABP/VABP:Acinetobacter baumannii complex, Escherichia coli*, Enterobacter cloacae complex*, Klebsiella pneumoniae*, Pseudomonas aeruginosa*, Serratia marcescens

• Study highlights: – Meropenem was used as a comparator in the trial and was

optimized (2 grams IV over 3 h q8h) for seriously ill patients with a multidrug-resistant Gram-negative infection in the ICU1

– 60% of patients were ventilated, while approximately 33% had failed empiric treatment1,5

– The top 5 baseline Gram-negative pathogens were K pneumoniae, P aeruginosa, A baumannii, E coli, and E cloacae5

• At Day 14, all-cause mortality (primary endpoint) in the mITT population was 12.4% for Fetroja vs 12.2% for extended-infusion, high-dose meropenem (95% CI, -7.2, 7.7)1

• Fetroja exhibited comparable safety vs extended-infusion, high-dose meropenem in HABP/VABP1

0 20 40 60 80 100

PERCENT

Overall

Overall

Overall

Overall




100%

100%

98%

90%

97%

95%

85%

(n=25,995)

(n=6213)

(n=814)

(n=1416)

(n=4185)

(n=1565)

(n=2274)

Enterobacteralesa

P aeruginosaa

Enterobacteralesa

P aeruginosaa


S maltophiliab


(inherently carbapenem-resistant)5,7

In a phylogenetic reclassification performed in 2016, the nomenclature of Enterobacterales was proposed, which includes formerly established Enterobacteriaceae family and other genera such as Proteus spp, Providencia spp, Photorhabdus spp, and Serratia spp.8

CI=confidence interval.

S:15"S:10.5"

T:17"T:11"

B:17.25"B:11.25"





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81156-12 Fetroja Brief Master_RGB.pdf (85%; 38KB)

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_ _

FETROJA (cefiderocol) for injection, for intravenous use Initial U.S. Approval: 2019 BRIEF SUMMARY: Please see package insert for full prescribing information. 1 INDICATIONS AND USAGE 1.1 Complicated Urinary Tract Infections (cUTIs), Including Pyelonephritis FETROJA® is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex [see Clinical Studies (14.1) in the full prescribing information]. 1.2 Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial

Pneumonia (HABP/VABP) FETROJA is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens [see Clinical Studies (14.2) in the full prescribing information]. 1.3 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of FETROJA and other antibacterial drugs, FETROJA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 4 CONTRAINDICATIONS FETROJA is contraindicated in patients with a known history of severe hypersensitivity to cefiderocol or other beta-lactam antibacterial drugs, or any other component of FETROJA [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)]. 5 WARNINGS AND PRECAUTIONS 5.1 Increase in All-Cause Mortality in Patients with Carbapenem-Resistant

Gram-Negative Bacterial Infections An increase in all-cause mortality was observed in patients treated with FETROJA as compared to best available therapy (BAT) in a multinational, randomized, open-label trial in critically ill patients with carbapenem-resistant Gram-negative bacterial infections (NCT02714595). Patients with nosocomial pneumonia, bloodstream infections, sepsis, or cUTI were included in the trial. BAT regimens varied according to local practices and consisted of 1 to 3 antibacterial drugs with activity against Gram-negative bacteria. Most of the BAT regimens contained colistin. The increase in all-cause mortality occurred in patients treated for nosocomial pneumonia, bloodstream infections, or sepsis. The 28-Day all-cause mortality was higher in patients treated with FETROJA than in patients treated with BAT [25/101 (24.8%) vs. 9/49 (18.4%), treatment difference 6.4%, 95% CI (-8.6, 19.2)]. All-cause mortality remained higher in patients treated with FETROJA than in patients treated with BAT through Day 49 [34/101 (33.7%) vs. 10/49 (20.4%), treatment difference 13.3%, 95% CI (-2.5, 26.9)]. Generally, deaths were in patients with infections caused by Gram-negative organisms, including non-fermenters such as Acinetobacter baumannii complex, Stenotrophomonas maltophilia, and Pseudomonas aeruginosa, and were the result of worsening or complications of infection, or underlying comorbidities. The cause of the increase in mortality has not been established. Closely monitor the clinical response to therapy in patients with cUTI and HABP/VABP. 5.2 Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Hypersensitivity was observed in FETROJA-treated patients in clinical trials [see Adverse Reactions (6.1)]. These reactions are more likely to occur in individuals with a history of beta-lactam hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before therapy with FETROJA is instituted, inquire about previous hypersensitivity reactions to cephalosporins, penicillins, or other beta-lactam antibacterial drugs. Discontinue FETROJA if an allergic reaction occurs. 5.3 Clostridioides difficile-associated Diarrhea (CDAD) Clostridioides difficile-associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial agents, including FETROJA. CDAD may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of C. difficile. C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, antibacterial drugs not directed against C. difficile may need to be discontinued. Manage fluid and electrolyte levels as appropriate, supplement protein intake, monitor antibacterial treatment of C. difficile, and institute surgical evaluation as clinically indicated. 5.4 Seizures and Other Central Nervous System (CNS) Adverse Reactions Cephalosporins, including FETROJA, have been implicated in triggering seizures [see Adverse Reactions (6.1)]. Nonconvulsive status epilepticus (NCSE), encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia have been reported with cephalosporins particularly in patients with a history of epilepsy and/or when recommended dosages of cephalosporins were exceeded due to renal impairment. Adjust FETROJA dosing based on creatinine clearance [see Dosage and Administration (2.2) in the full prescribing information]. Anticonvulsant therapy should be continued in patients with known seizure disorders. If CNS adverse reactions including seizures occur, patients should undergo a neurological evaluation to determine whether FETROJA should be discontinued. 5.5 Development of Drug-Resistant Bacteria Prescribing FETROJA in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria [see Indications and Usage (1.3)]. 6 ADVERSE REACTIONS The following serious adverse reactions are described in greater detail in the Warnings and Precautions section: • Increase in All-Cause Mortality in Patients with Carbapenem-Resistant Gram-Negative

Bacterial Infections [see Warnings and Precautions (5.1)] • Hypersensitivity Reactions [see Warnings and Precautions (5.2)] • Clostridioides difficile-associated Diarrhea (CDAD) [see Warnings and Precautions (5.3)] • Seizures and Other Central Nervous System Adverse Reactions [see Warnings and

Precautions (5.4)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Complicated Urinary Tract Infections (cUTIs), Including Pyelonephritis FETROJA was evaluated in an active-controlled, randomized clinical trial in patients with cUTI, including pyelonephritis (Trial 1). In this trial, 300 patients received FETROJA 2 grams every 8 hours infused over 1 hour (or a renally-adjusted dose), and 148 patients were treated with imipenem/cilastatin 1gram/1gram every 8 hours infused over 1 hour (or a renally-adjusted dose). The median age of treated patients across treatment arms was 65 years (range 18 to 93 years), with approximately 53% of patients aged greater than or equal to 65. Approximately 96% of patients were White, most were from Europe, and 55% were female. Patients across treatment arms received treatment for a median duration of 9 days. Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation In Trial 1, a total of 14/300 (4.7%) cUTI patients treated with FETROJA and 12/148 (8.1%) of cUTI patients treated with imipenem/cilastatin experienced serious adverse reactions. One death (0.3%) occurred in 300 patients treated with FETROJA as compared to none treated with imipenem/cilastatin. Discontinuation of treatment due to any adverse reaction occurred in 5/300 (1.7%) of patients treated with FETROJA and 3/148 (2.0%) of patients treated with imipenem/cilastatin. Specific adverse reactions leading to treatment discontinuation in patients who received FETROJA included diarrhea (0.3%), drug hypersensitivity (0.3%), and increased hepatic enzymes (0.3%). Common Adverse Reactions Table 4 lists the most common selected adverse reactions occurring in ≥ 2% of cUTI patients receiving FETROJA in Trial 1.

(continued)

Table 4 Selected Adverse Reactions Occurring in ≥ 2% of cUTI Patients Receiving FETROJA in Trial 1

Adverse Reaction FETROJAa (N = 300)

Imipenem/Cilastatinb (N = 148)

Diarrhea 4% 6%

Infusion site reactionsc 4% 5%

Constipation 3% 4%

Rashd 3% < 1%

Candidiasise 2% 3%

Cough 2% < 1%

Elevations in liver testsf 2% < 1%

Headache 2% 5%

Hypokalemiag 2% 3%

Other Adverse Reactions of FETROJA in the cUTI Patients (Trial 1) The following selected adverse reactions were reported in FETROJA-treated cUTI patients at a rate of less than 2% in Trial 1: Blood and lymphatic disorders: thrombocytosis Cardiac disorders: congestive heart failure, bradycardia, atrial fibrillation Gastrointestinal disorders: abdominal pain, dry mouth, stomatitis General system disorders: pyrexia, peripheral edema Hepatobiliary disorders: cholelithiasis, cholecystitis, gallbladder pain Immune system disorders: drug hypersensitivity Infections and infestations: C. difficile infection Laboratory investigations: prolonged prothrombin time (PT) and prothrombin time international normalized ratio (PT-INR), red blood cells urine positive, creatine phosphokinase increase Metabolism and nutrition disorders: decreased appetite, hypocalcemia, fluid overload Nervous system disorders: dysgeusia, seizure Respiratory, thoracic, and mediastinal disorders: dyspnea, pleural effusion Skin and subcutaneous tissue disorders: pruritis Psychiatric disorders: insomnia, restlessness Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP) FETROJA was evaluated in an active-controlled clinical trial in patients with HABP/VABP (Trial 2). In this trial, 148 patients received FETROJA 2 grams every 8 hours infused over 3 hours, and 150 patients received meropenem 2 grams every 8 hours infused over 3 hours. Doses of study treatments were adjusted based on renal function. The median age was 67 years, approximately 59% of patients were 65 years of age and older, 69% were male, and 68% were White. Overall, approximately 60% were ventilated at randomization, including 41% with VABP and 14% with ventilated HABP. The mean Acute Physiology And Chronic Health Evaluation (APACHE II) score was 16. All patients received empiric treatment for Gram-positive organisms with linezolid for at least 5 days. Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation In Trial 2, serious adverse reactions occurred in 54/148 (36.5%) HABP/VABP patients treated with FETROJA and 45/150 (30%) of HABP/VABP patients treated with meropenem. Adverse reactions leading to death were reported in 39/148 (26.4%) patients treated with FETROJA and 35/150 (23.3%) patients treated with meropenem. Adverse reactions leading to discontinuation of treatment occurred in 12/148 (8.1%) of patients treated with FETROJA and 14/150 (9.3%) of patients treated with meropenem. The most common adverse reactions leading to discontinuation in both treatment groups were elevated liver tests. Common Adverse Reactions Table 5 lists the most common selected adverse reactions occurring in ≥ 4% of patients receiving FETROJA in the HABP/VABP trial.

Other Adverse Reactions of FETROJA in HABP/VABP Patients in Trial 2 The following selected adverse reactions were reported in FETROJA-treated HABP/VABP patients at a rate of less than 4% in Trial 2: Blood and lymphatic disorders: thrombocytopenia, thrombocytosis Cardiac disorders: myocardial infarction, atrial flutter Gastrointestinal disorders: nausea, vomiting, abdominal pain Hepatobiliary disorders: cholecystitis, cholestasis Infections and infestations: C. difficile infection, oral candidiasis Laboratory investigations: prolonged prothrombin time (PT) and prothrombin time international normalized ratio (PT-INR), activated partial thromboplastin time (aPTT) Metabolism and nutrition disorders: hypocalcemia, hyperkalemia Nervous system disorders: seizure Renal and genitourinary disorders: acute interstitial nephritis Respiratory, thoracic, and mediastinal disorders: cough Skin and subcutaneous tissue disorders: rash including rash erythematous 7 DRUG INTERACTIONS 7.1 Drug/Laboratory Test Interactions Cefiderocol may result in false-positive results in dipstick tests (urine protein, ketones, or occult blood). Use alternate clinical laboratory methods of testing to confirm positive tests. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no available data on FETROJA use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Available data from published prospective cohort studies, case series, and case reports over several decades with cephalosporin use in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Developmental toxicity studies with cefiderocol administered during organogenesis to rats and mice showed no evidence of embryo-fetal toxicity, including drug-induced fetal malformations, at doses providing exposure levels 0.9 times (rats) or 1.3 times (mice) higher than the average observed in patients receiving the maximum recommended daily dose. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data While available studies cannot definitively establish the absence of risk, published data from prospective cohort studies, case series, and case reports over several decades have not identified an association with cephalosporin use during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. Animal Data Developmental toxicity was not observed in rats at intravenous doses of up to 1000 mg/kg/day or mice at subcutaneous doses of up to 2000 mg/kg/day given during the period of organogenesis (gestation days 6-17 in rats and 6-15 in mice). No treatment-related malformations or reductions in fetal viability were observed. Mean plasma exposure (AUC) at these doses was approximately 0.9 times (rats) and 1.3 times (mice) the daily mean plasma exposure in patients that received 2 grams of cefiderocol infused intravenously every 8 hours. In a pre- and postnatal development study, cefiderocol was administered intravenously at doses up to 1000 mg/kg/day to rats from Day 6 of pregnancy until weaning. No adverse effects on parturition, maternal function, or pre- and postnatal development and viability of the pups were observed. In pregnant rats, cefiderocol-derived radioactivity was shown to cross the placenta, but the amount detected in fetuses was a small percentage (< 0.5%) of the dose. 8.2 Lactation Risk Summary It is not known whether cefiderocol is excreted into human milk; however, cefiderocol-derived radioactivity was detected in the milk of lactating rats that received the drug intravenously. When a drug is present in animal milk, it is likely that the drug will be present in human milk. No information is available on the effects of FETROJA on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for FETROJA and any potential adverse effects on the breastfed child from FETROJA or from the underlying maternal condition.




Nausea 2% 4%

Vomiting 2% 1%

cUTI = complicated urinary tract infection. a 2 grams IV over 1 hour every 8 hours (with dosing adjustment based on renal function). b 1 gram IV over 1 hour every 8 hours (with dosing adjustment based on renal function and body

weight). c Infusion site reactions include infusion site erythema, inflammation, pain, pruritis, injection site

pain, and phlebitis. d Rash includes rash macular, rash maculopapular, erythema, skin irritation. e Candidiasis includes oral or vulvovaginal candidiasis, candiduria. f Elevations in liver tests include alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, blood alkaline phosphatase, hepatic enzyme increased.

g Hypokalemia includes blood potassium decreased.

Table 5 Selected Adverse Reactions Occurring in ≥ 4% of HABP/VABP Patients Receiving FETROJA in Trial 2

Adverse Reaction FETROJAa N = 148

Meropenemb N = 150

Elevations in liver testsc 16% 16%

Hypokalemiad 11% 15%

Diarrhea 9% 9%

Hypomagnesemia 5% < 1%Atrial fibrillation 5% 3%

HABP/VABP = hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. a 2 grams IV over 3 hours every 8 hours (with dosing adjustment based on renal function). b 2 grams IV over 3 hours every 8 hours (with dosing adjustment based on renal function). c Elevations in liver tests include the following terms: aspartate aminotransferase increased,

alanine aminotransferase increased, gamma-glutamyl transferase increased, liver function test increased, liver function test abnormal, hepatic enzyme increased, transaminases increased, hypertransaminesemia.

d Hypokalemia includes blood potassium decreased.

S:15"

S:10.5"

T:17"

T:11"

B:17.25"

B:11.25"





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81156-12 Fetroja Brief Master_RGB.pdf (85%; 38KB)

Scale: 1" = 1"




_ _

FETROJA (cefiderocol) for injection, for intravenous use Initial U.S. Approval: 2019 BRIEF SUMMARY: Please see package insert for full prescribing information. 1 INDICATIONS AND USAGE 1.1 Complicated Urinary Tract Infections (cUTIs), Including Pyelonephritis FETROJA® is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex [see Clinical Studies (14.1) in the full prescribing information]. 1.2 Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial

Pneumonia (HABP/VABP) FETROJA is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens [see Clinical Studies (14.2) in the full prescribing information]. 1.3 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of FETROJA and other antibacterial drugs, FETROJA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 4 CONTRAINDICATIONS FETROJA is contraindicated in patients with a known history of severe hypersensitivity to cefiderocol or other beta-lactam antibacterial drugs, or any other component of FETROJA [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)]. 5 WARNINGS AND PRECAUTIONS 5.1 Increase in All-Cause Mortality in Patients with Carbapenem-Resistant

Gram-Negative Bacterial Infections An increase in all-cause mortality was observed in patients treated with FETROJA as compared to best available therapy (BAT) in a multinational, randomized, open-label trial in critically ill patients with carbapenem-resistant Gram-negative bacterial infections (NCT02714595). Patients with nosocomial pneumonia, bloodstream infections, sepsis, or cUTI were included in the trial. BAT regimens varied according to local practices and consisted of 1 to 3 antibacterial drugs with activity against Gram-negative bacteria. Most of the BAT regimens contained colistin. The increase in all-cause mortality occurred in patients treated for nosocomial pneumonia, bloodstream infections, or sepsis. The 28-Day all-cause mortality was higher in patients treated with FETROJA than in patients treated with BAT [25/101 (24.8%) vs. 9/49 (18.4%), treatment difference 6.4%, 95% CI (-8.6, 19.2)]. All-cause mortality remained higher in patients treated with FETROJA than in patients treated with BAT through Day 49 [34/101 (33.7%) vs. 10/49 (20.4%), treatment difference 13.3%, 95% CI (-2.5, 26.9)]. Generally, deaths were in patients with infections caused by Gram-negative organisms, including non-fermenters such as Acinetobacter baumannii complex, Stenotrophomonas maltophilia, and Pseudomonas aeruginosa, and were the result of worsening or complications of infection, or underlying comorbidities. The cause of the increase in mortality has not been established. Closely monitor the clinical response to therapy in patients with cUTI and HABP/VABP. 5.2 Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Hypersensitivity was observed in FETROJA-treated patients in clinical trials [see Adverse Reactions (6.1)]. These reactions are more likely to occur in individuals with a history of beta-lactam hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before therapy with FETROJA is instituted, inquire about previous hypersensitivity reactions to cephalosporins, penicillins, or other beta-lactam antibacterial drugs. Discontinue FETROJA if an allergic reaction occurs. 5.3 Clostridioides difficile-associated Diarrhea (CDAD) Clostridioides difficile-associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial agents, including FETROJA. CDAD may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of C. difficile. C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, antibacterial drugs not directed against C. difficile may need to be discontinued. Manage fluid and electrolyte levels as appropriate, supplement protein intake, monitor antibacterial treatment of C. difficile, and institute surgical evaluation as clinically indicated. 5.4 Seizures and Other Central Nervous System (CNS) Adverse Reactions Cephalosporins, including FETROJA, have been implicated in triggering seizures [see Adverse Reactions (6.1)]. Nonconvulsive status epilepticus (NCSE), encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia have been reported with cephalosporins particularly in patients with a history of epilepsy and/or when recommended dosages of cephalosporins were exceeded due to renal impairment. Adjust FETROJA dosing based on creatinine clearance [see Dosage and Administration (2.2) in the full prescribing information]. Anticonvulsant therapy should be continued in patients with known seizure disorders. If CNS adverse reactions including seizures occur, patients should undergo a neurological evaluation to determine whether FETROJA should be discontinued. 5.5 Development of Drug-Resistant Bacteria Prescribing FETROJA in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria [see Indications and Usage (1.3)]. 6 ADVERSE REACTIONS The following serious adverse reactions are described in greater detail in the Warnings and Precautions section: • Increase in All-Cause Mortality in Patients with Carbapenem-Resistant Gram-Negative

Bacterial Infections [see Warnings and Precautions (5.1)] • Hypersensitivity Reactions [see Warnings and Precautions (5.2)] • Clostridioides difficile-associated Diarrhea (CDAD) [see Warnings and Precautions (5.3)] • Seizures and Other Central Nervous System Adverse Reactions [see Warnings and

Precautions (5.4)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Complicated Urinary Tract Infections (cUTIs), Including Pyelonephritis FETROJA was evaluated in an active-controlled, randomized clinical trial in patients with cUTI, including pyelonephritis (Trial 1). In this trial, 300 patients received FETROJA 2 grams every 8 hours infused over 1 hour (or a renally-adjusted dose), and 148 patients were treated with imipenem/cilastatin 1gram/1gram every 8 hours infused over 1 hour (or a renally-adjusted dose). The median age of treated patients across treatment arms was 65 years (range 18 to 93 years), with approximately 53% of patients aged greater than or equal to 65. Approximately 96% of patients were White, most were from Europe, and 55% were female. Patients across treatment arms received treatment for a median duration of 9 days. Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation In Trial 1, a total of 14/300 (4.7%) cUTI patients treated with FETROJA and 12/148 (8.1%) of cUTI patients treated with imipenem/cilastatin experienced serious adverse reactions. One death (0.3%) occurred in 300 patients treated with FETROJA as compared to none treated with imipenem/cilastatin. Discontinuation of treatment due to any adverse reaction occurred in 5/300 (1.7%) of patients treated with FETROJA and 3/148 (2.0%) of patients treated with imipenem/cilastatin. Specific adverse reactions leading to treatment discontinuation in patients who received FETROJA included diarrhea (0.3%), drug hypersensitivity (0.3%), and increased hepatic enzymes (0.3%). Common Adverse Reactions Table 4 lists the most common selected adverse reactions occurring in ≥ 2% of cUTI patients receiving FETROJA in Trial 1.

(continued)




Diarrhea 4% 6%

Infusion site reactionsc 4% 5%

Constipation 3% 4%

Rashd 3% < 1%

Candidiasise 2% 3%

Cough 2% < 1%

Elevations in liver testsf 2% < 1%

Headache 2% 5%

Hypokalemiag 2% 3%

Other Adverse Reactions of FETROJA in the cUTI Patients (Trial 1) The following selected adverse reactions were reported in FETROJA-treated cUTI patients at a rate of less than 2% in Trial 1: Blood and lymphatic disorders: thrombocytosis Cardiac disorders: congestive heart failure, bradycardia, atrial fibrillation Gastrointestinal disorders: abdominal pain, dry mouth, stomatitis General system disorders: pyrexia, peripheral edema Hepatobiliary disorders: cholelithiasis, cholecystitis, gallbladder pain Immune system disorders: drug hypersensitivity Infections and infestations: C. difficile infection Laboratory investigations: prolonged prothrombin time (PT) and prothrombin time international normalized ratio (PT-INR), red blood cells urine positive, creatine phosphokinase increase Metabolism and nutrition disorders: decreased appetite, hypocalcemia, fluid overload Nervous system disorders: dysgeusia, seizure Respiratory, thoracic, and mediastinal disorders: dyspnea, pleural effusion Skin and subcutaneous tissue disorders: pruritis Psychiatric disorders: insomnia, restlessness Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP) FETROJA was evaluated in an active-controlled clinical trial in patients with HABP/VABP (Trial 2). In this trial, 148 patients received FETROJA 2 grams every 8 hours infused over 3 hours, and 150 patients received meropenem 2 grams every 8 hours infused over 3 hours. Doses of study treatments were adjusted based on renal function. The median age was 67 years, approximately 59% of patients were 65 years of age and older, 69% were male, and 68% were White. Overall, approximately 60% were ventilated at randomization, including 41% with VABP and 14% with ventilated HABP. The mean Acute Physiology And Chronic Health Evaluation (APACHE II) score was 16. All patients received empiric treatment for Gram-positive organisms with linezolid for at least 5 days. Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation In Trial 2, serious adverse reactions occurred in 54/148 (36.5%) HABP/VABP patients treated with FETROJA and 45/150 (30%) of HABP/VABP patients treated with meropenem. Adverse reactions leading to death were reported in 39/148 (26.4%) patients treated with FETROJA and 35/150 (23.3%) patients treated with meropenem. Adverse reactions leading to discontinuation of treatment occurred in 12/148 (8.1%) of patients treated with FETROJA and 14/150 (9.3%) of patients treated with meropenem. The most common adverse reactions leading to discontinuation in both treatment groups were elevated liver tests. Common Adverse Reactions Table 5 lists the most common selected adverse reactions occurring in ≥ 4% of patients receiving FETROJA in the HABP/VABP trial.

Other Adverse Reactions of FETROJA in HABP/VABP Patients in Trial 2 The following selected adverse reactions were reported in FETROJA-treated HABP/VABP patients at a rate of less than 4% in Trial 2: Blood and lymphatic disorders: thrombocytopenia, thrombocytosis Cardiac disorders: myocardial infarction, atrial flutter Gastrointestinal disorders: nausea, vomiting, abdominal pain Hepatobiliary disorders: cholecystitis, cholestasis Infections and infestations: C. difficile infection, oral candidiasis Laboratory investigations: prolonged prothrombin time (PT) and prothrombin time international normalized ratio (PT-INR), activated partial thromboplastin time (aPTT) Metabolism and nutrition disorders: hypocalcemia, hyperkalemia Nervous system disorders: seizure Renal and genitourinary disorders: acute interstitial nephritis Respiratory, thoracic, and mediastinal disorders: cough Skin and subcutaneous tissue disorders: rash including rash erythematous 7 DRUG INTERACTIONS 7.1 Drug/Laboratory Test Interactions Cefiderocol may result in false-positive results in dipstick tests (urine protein, ketones, or occult blood). Use alternate clinical laboratory methods of testing to confirm positive tests. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no available data on FETROJA use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Available data from published prospective cohort studies, case series, and case reports over several decades with cephalosporin use in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Developmental toxicity studies with cefiderocol administered during organogenesis to rats and mice showed no evidence of embryo-fetal toxicity, including drug-induced fetal malformations, at doses providing exposure levels 0.9 times (rats) or 1.3 times (mice) higher than the average observed in patients receiving the maximum recommended daily dose. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data While available studies cannot definitively establish the absence of risk, published data from prospective cohort studies, case series, and case reports over several decades have not identified an association with cephalosporin use during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. Animal Data Developmental toxicity was not observed in rats at intravenous doses of up to 1000 mg/kg/day or mice at subcutaneous doses of up to 2000 mg/kg/day given during the period of organogenesis (gestation days 6-17 in rats and 6-15 in mice). No treatment-related malformations or reductions in fetal viability were observed. Mean plasma exposure (AUC) at these doses was approximately 0.9 times (rats) and 1.3 times (mice) the daily mean plasma exposure in patients that received 2 grams of cefiderocol infused intravenously every 8 hours. In a pre- and postnatal development study, cefiderocol was administered intravenously at doses up to 1000 mg/kg/day to rats from Day 6 of pregnancy until weaning. No adverse effects on parturition, maternal function, or pre- and postnatal development and viability of the pups were observed. In pregnant rats, cefiderocol-derived radioactivity was shown to cross the placenta, but the amount detected in fetuses was a small percentage (< 0.5%) of the dose. 8.2 Lactation Risk Summary It is not known whether cefiderocol is excreted into human milk; however, cefiderocol-derived radioactivity was detected in the milk of lactating rats that received the drug intravenously. When a drug is present in animal milk, it is likely that the drug will be present in human milk. No information is available on the effects of FETROJA on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for FETROJA and any potential adverse effects on the breastfed child from FETROJA or from the underlying maternal condition.




Nausea 2% 4%

Vomiting 2% 1%

cUTI = complicated urinary tract infection. a 2 grams IV over 1 hour every 8 hours (with dosing adjustment based on renal function). b 1 gram IV over 1 hour every 8 hours (with dosing adjustment based on renal function and body

weight). c Infusion site reactions include infusion site erythema, inflammation, pain, pruritis, injection site

pain, and phlebitis. d Rash includes rash macular, rash maculopapular, erythema, skin irritation. e Candidiasis includes oral or vulvovaginal candidiasis, candiduria. f Elevations in liver tests include alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, blood alkaline phosphatase, hepatic enzyme increased.

g Hypokalemia includes blood potassium decreased.

Table 5 Selected Adverse Reactions Occurring in ≥ 4% of HABP/VABP Patients Receiving FETROJA in Trial 2

Adverse Reaction FETROJAa N = 148

Meropenemb N = 150

Elevations in liver testsc 16% 16%

Hypokalemiad 11% 15%

Diarrhea 9% 9%

Hypomagnesemia 5% < 1%Atrial fibrillation 5% 3%

HABP/VABP = hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. a 2 grams IV over 3 hours every 8 hours (with dosing adjustment based on renal function). b 2 grams IV over 3 hours every 8 hours (with dosing adjustment based on renal function). c Elevations in liver tests include the following terms: aspartate aminotransferase increased,

alanine aminotransferase increased, gamma-glutamyl transferase increased, liver function test increased, liver function test abnormal, hepatic enzyme increased, transaminases increased, hypertransaminesemia.

d Hypokalemia includes blood potassium decreased.

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Data Cefiderocol-derived radioactivity was detected in milk following intravenous administration to lactating rats. The peak level in rat milk was approximately 6% of the peak plasma level. 8.4 Pediatric Use Safety and effectiveness of FETROJA in pediatric patients younger than 18 years of age have not been established. 8.5 Geriatric Use cUTI Of the 300 patients treated with FETROJA in the cUTI trial, 158 (52.7%) were 65 years of age and older, and 67 (22.3%) were 75 years of age and older. No overall differences in safety or efficacy were observed between these patients and younger patients. HABP/VABP Of the 148 patients treated with FETROJA in the HABP/VABP trial, 83 (56.1%) were 65 years of age and older, and 40 (27%) were 75 years of age and older. The incidence of adverse reactions in patients treated with FETROJA was similar in patients under 65 years of age as compared to older patients (65 years of age and older and 75 years of age and older). The incidence of adverse reactions in older patients (65 years of age and older and 75 years of age and older) was also similar between treatment groups. Clinical cure rates at the Test-of-Cure visit (TOC) in FETROJA-treated adult patients younger than 65 years of age, 65 years of age to younger than 75 years of age and 75 years of age and older were 60%, 77.5%, and 60%, respectively. In comparison, the clinical cure rates at the TOC visit in the meropenem-treated patients for each of these subgroups were 65.5%, 64.4%, and 70.5%, respectively. The observed all-cause mortality rates at Day 14 in the FETROJA-treated patients for each of these subgroups were 12.3%, 7.5%, and 17.5%, respectively. In comparison, in the meropenem-treated patients for each of these subgroups, they were 10.3%, 17.8%, and 9.1%, respectively. cUTI and HABP/VABP FETROJA is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. No dosage adjustment is required based on age. Dosage adjustment for elderly patients should be based on renal function [see Dosage and Administration (2.2), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3) in the full prescribing information]. 8.6 Renal Impairment Patients with CLcr 60 to 89 mL/min No dosage adjustment of FETROJA is recommended in patients with CLcr 60 to 89 mL/min. Patients with CLcr Less Than 60 mL/min Including Patients Receiving Intermittent HD Dose adjustment is required in patients with CLcr less than 60 mL/min, and in patients who are receiving HD. In patients requiring HD, complete HD at the latest possible time before the start of cefiderocol dosing [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3) in the full prescribing information]. Monitor renal function regularly and adjust the dosage of FETROJA accordingly as renal function may change during the course of therapy.

Patients Receiving CRRT A total of 16 patients treated with FETROJA received CRRT in clinical trials. Dosage adjustment of FETROJA is required in patients receiving CRRT including CVVH, CVVHD, and CVVHDF. Dosage of FETROJA should be based on the effluent flow rate in patients receiving CRRT [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3) in the full prescribing information]. While on CRRT, a patient’s residual renal function may change. Improvements or reductions in residual renal function may warrant a change in FETROJA dosage. Patients with CLcr 120 mL/min or Greater CLcr 120 mL/min or greater may be seen in seriously ill patients, who are receiving intravenous fluid resuscitation. Dosage adjustment of FETROJA is required in patients with CLcr 120 mL/min or greater [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3) in the full prescribing information]. Monitor renal function regularly and adjust the dosage of FETROJA accordingly as renal function may change during the course of therapy. 8.7 Hepatic Impairment The effects of hepatic impairment on the pharmacokinetics of cefiderocol have not been evaluated. Hepatic impairment is not expected to alter the elimination of cefiderocol as hepatic metabolism/excretion represents a minor pathway of elimination for cefiderocol. Dosage adjustments are not necessary in patients with impaired hepatic function. 10 OVERDOSAGE There is no information on clinical signs and symptoms associated with an overdose of FETROJA. Patients who receive doses greater than the recommended dose regimen and have unexpected adverse reactions possibly associated with FETROJA should be carefully observed and given supportive treatment, and discontinuation or interruption of treatment should be considered. Approximately 60% of cefiderocol is removed by a 3- to 4-hour hemodialysis session [see Clinical Pharmacology (12.3) in the full prescribing information]. Manufactured by Shionogi & Co., Ltd. Osaka 541-0045 Japan Manufactured for Shionogi Inc. Florham Park, NJ USA, 07932 FET-PI-02A USFET-0247 09/20

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Friday, October 1, 2021 • 19IDWeek Daily News

Microbial GenomicsContinued from page 12

Can Precision Metagenomics Impact the Trajectory of COVID-19?

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Co-infections or secondary infections in patients with COVID-19 are often difficult to diagnose with conventional methods but are known to affect disease severity and can be fatal.

Learn how accurate detection and genomic profiling of pathogens with metagenomic next generation sequencing (mNGS) provide additional information to clinicians that may help them to change the disease trajectory for patients with COVID-19.

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but one place should provide the analytic resource.”

She’ll also explore how facilities can “get the flame lit” in terms of hospital outbreak detection and investigation as well as the barriers to applying sequencing.

“Can we get the narrative em-bedded that if we’re talking about sequencing, it must be part of a broader conversation?” asks Dr. Peacock. “It’s not the only problem that we have to face. Before we have finished off all the problems with SARS-CoV-2, we need to be facing up to the challenges of implementing long-term sequenc-ing. We still have major issues to deal with around data systems and data integration. We need lots of innovation in this space.”

That is all the more important because “sequencing is here to stay, and it’s going to be a central stage in infection discourse,” Dr. Peacock says. “There are other limitations such as training and accreditation, but that’s the same for many disciplines.”

Dr. Dantas will move away from COVID into antibiotic resistance: “This starts with a recognition of the hallmark of microbiology, this idea that single microbes need to be able to separate from their

natural habitat. Especially over the last few decades, we’ve learned that most microbes don’t live on their own, but in complex environ-ments. To appreciate antibiotic re-sistance, understanding resistance in the perspective of the communi-ty is required. It’s not either-or, but both.”

He will discuss his lab’s work in analyzing resistant genes, which draws its basis in “someone de-scribing that gene before. The prob-lem is that we’re being reactive.”

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Although antibiotics don’t treat COVID-19, COVID-19 may have significant impact

on antibiotics’ ability to treat other infections. The session “Code Blue: Resuscitating Antimicrobial Stewardship and Healthcare Epi-demiology Post-COVID” focused on the impact of COVID-19 on infection prevention and antibiotic stewardship as well as the road forward.

Catherine Passaretti, MD, med-ical director, infection prevention/associate professor, Atrium Health; Teena Chopra, MD, MPH, corpo-rate medical director of infection prevention and hospital epide-miology, Detroit Medical Center, Wayne State University; and Arjun Srinivasan, MD, associate director for healthcare associated infec-tion prevention programs, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, spoke at this important session.

Dr. Passaretti discussed the

impact of COVID-19 on infection prevention. “I was asked to do this talk on June 6. At that point, we were at a different place,” she said. “I thought I’d be closer to having COVID in my rearview mir-ror and could share all the won-derful lessons learned. That is not where we are. I will say this is what I’ve learned so far. I’m sure things will continue to change, and we’ll learn more things as we go on.”

She looked at the many factors that had an impact on hospital-acquired infections. While a reduc-tion in surgeries dropped the rate of surgical site infections, burnout and staff shortages had impacts elsewhere. “You’d be hard pressed in many areas and especially in smaller facilities, there are very few areas of COVID that have not touched the infection prevention department in some way, shape or form.”

ID and infection prevention professionals took on many more roles, including advising their facil-

ities on personal protective equip-ment acquisition during shortages. In the earliest days of the pandem-ic, there were employee concerns over the transmissibility of the virus. “I certainly had some very heated and lengthy discussions about shoe covers, hair covers and full-on Tyvek suits. With all these changes in PPE education, I now regularly talk to my materials management people,” Dr. Pas-saretti said.

COVID protocols were “invent-ed from scratch” and ID clinicians took lead roles in battling misinfor-mation. “For many of us, ID pro-vider and infection preventionists, we were not only giving education and advice within our facilities, but also in our communities,” she said.

Admitting that clinicians remain “in survival mode,” there are future questions about staffing for in-fection prevention and pandemic

Antibiotics and COVID: The Pandemic’s Impact on Stewardship


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Hospitals and other health care facilities should require employees to be vaccinated

against COVID-19, according to a consensus statement by SHEA and six other leading organizations representing medical profession-als working in infectious diseases, infection prevention, pharmacy, pediatrics and long-term care. The paper specifies exemption for those with medical contraindica-tions and some other circumstanc-es in compliance with federal and state laws.

“The COVID-19 vaccines in use in the United States have been shown to be safe and effective,”

said David J. Weber, a member of the SHEA Board of Trustees and lead author of the statement. “By requiring vaccination as a con-dition of employment, we raise levels of vaccination for health care personnel, improve protection of our patients and aid in reaching community protection. As health care personnel, we’re committed to these goals.”

SHEA convened a multi-organizational panel of experts in infectious disease prevention, law and human resources, with rep-resentatives from AMDA — The Society for Post-Acute and Long-Term Care Medicine, the Associa-

tion for Professionals in Infection Control and Epidemiology, IDSA, HIVMA, PIDS and SIDP. The panel conducted an eight-week review of evidence on the three vaccines

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and shut case for a vaccine, how-ever. There is natural immunity, raising the question, as Dr. Falsey says, “‘Can you do better than nature?’”

That answer came when NIH researchers were able to stabilize the protein. “It induces very potent neutralizing antibodies. It’s going to be a game changer,” Dr. Falsey says. With several in development, she believes a vaccine may not be far off, with a target population of pregnant women and the elderly or adults with chronic conditions.

She will focus much of her lecture on the development of an RSV vaccine in a bid to Enders: “His contributions to vaccinology were astonishing.”

Equally astonishing, to her at least, was her selection for the Enders lecture. “I thought they made a mistake,” she admits. “You can imagine that the last 18 months have been very stressful and difficult for people working in the field of respiratory viruses. It’s that little shot in the arm that you need to keep going.”

Dr. Stanley A. Plotkin Lectureship in Vaccinology

Bill Gruber, MD, FIDSA, will of-fer a one-of-a-kind “peek behind the curtain” at the development of the Pfizer COVID-19 vaccine. He had a front row seat as senior vice president of vaccine clinical research and development at Pfizer Inc.

“Having lived in the academic world over my career, it’s a lit-tle opaque what happens at the industry level to meet the require-ments and also to manufacture and to engage in the regulatory discussions that allow a vaccine

to move from Phase I to Phase III,” says Dr. Gruber.

He believes his talk will shed light on not only the safety and effica-cy of the vaccine, but also explain “the study that delivers this type of information and how it is used by regulatory officials at each step.”

Beyond the specific story of the breakneck speed of COVID-19 vaccine development, though, Dr. Gruber believes that this provides a roadmap to future vaccine devel-opment. He says, “When there is a concerted need for something like in a pandemic, it’s very possible to align academic public health, industry and government and govern in a way that everybody is rowing together.”

In his 35 years in vaccine devel-opment, the COVID-19 vaccine de-velopment marked the first time one vaccine went from study to Phase III in the same trial. “It was because of the ability to look and interact with the FDA in particular, being able to evaluate data in real time so that you kept the train moving. There is a fair amount of skepticism that this was rushed. No shortcuts were taken in terms of the requirements for safety and efficacy. We took up the white space that normally exists when dealing with a regulatory agency,” says Dr. Gruber.

Data were submitted in real time, and approval was swift. “We were working 16 and 18 hours a day, and still, 16- and 18-hour days are pret-ty common. The work’s not done yet,” he says.

The work of vaccine development goes hand in hand with “acting as a vaccine advocate to help educate the public and put them in contact with people who can reassure them in a way they find satisfying,” Dr. Gruber says. “We live in a remark-able time. We have all these tools at our disposal to develop lifesav-ing vaccines that can have a tre-

mendous impact on public health throughout the world. We have the skills to be even more reassured about the safety and efficacy based on the way we collect data. At the same time, we have probably one of the worst periods of time in terms of vaccine hesitancy.”

To present the lecture named for Dr. Plotkin is “a high honor,” Dr. Gruber says. “Dr. Stanley Plotkin is the father of vaccines development, and he was a pivotal part of the team that developed vaccines for rubella and rabies. I look to him as the example. I know he’s in his 80s and he’s still going strong.”

Joseph E. Smadel LectureIn a time of so much uncertainty,

Keith Klugman, MD, PhD, FIDSA, brings a bit of hope, discussing innovations that are improving mor-tality rates for infants around the world. Dr. Klugman, now director of the pneumonia program at the Bill and Melinda Gates Founda-tion, has long worked in the field and believes “it’s one of the best public health stories in the last 30 years, that the number of childhood deaths has dramatically decreased, a more than 50 percent reduction in that time.”

But nearly half of all children who die do so within the first month of life, he says. Pneumonia is the leading cause of infant death.

While the pneumococcal vaccine PCV is given routinely in wealthier countries, it is pricey and unavail-able elsewhere. Gavi, the Vaccine Alliance, spent about 40 percent of its budget on PCV pre-COVID. The Gates Foundation is exploring how to reduce that cost. “The main thrust is how we are working to try and get developing company man-ufacturers to make the product.

LecturesContinued from page 2



We’re also investigating whether the current recommended two dos-es and a booster could be reduced to one early dose and a booster six months later,” says Dr. Klugman.

Early research has proven that theory out, and Dr. Klugman says the United Kingdom has already made the switch. “If it weren’t for COVID, we would anticipate that more middle-income and poor countries could go that way. That may make it more sustainable and reduce the burden of countries paying for it,” he says.

Other vaccination programs are aimed at immunizing mothers to pro-tect infants: “If you want to protect babies in the first month of life, you have to immunize them the day they are born, and it’s possible, but not easy to induce a protected immune response on the first day of life.”

Maternal immunization delivers that protection from day one, and an RSV vaccine may be one of the first major developments. Using the same mRNA approach used in COVID vaccines could lead to quick development of an RSV vaccine, Dr. Klugman believes. Other infections like whooping cough, influenza and group B Streptococcus also are pri-orities. He also will discuss his belief that a vaccine for Klebsiella is also potentially on the horizon, which would reduce deaths for babies born in hospitals and clinics.

“On the one hand, there is a lot of optimism that infant deaths have come down,” Dr. Klugman says. “There are a number of existing vaccines that could be better deployed. But we are optimistic that we may soon have three new vaccines for maternal health.”

Dr. Klugman first practiced medicine in South Africa, “where

One key element worth remem-bering is how ID professionals have stepped into the breach. “We should feel incredibly proud of what we’ve been able to achieve over the past two years,” says Dr. Yokoe. “I don’t know a single col-league who hasn’t gone above and beyond the call of duty during the pandemic to provide the best pa-tient care and to create the safest health care environment possible. You are all heroes.”

But the work is far from done. With a better understanding of just how ID can contribute to the broad-er health care field, ID professionals should not miss the opportunity to highlight “the key roles that we’ve all played in the pandemic response and the negative impacts on pa-tient outcomes when resources are diverted away from core infection prevention and antimicrobial stew-ardship activities,” Dr. Yokoe says.

This also should be used to inspire others to join the field. And, Dr. Yokoe adds, “in the spirit of making lemons into lemonade, we should think about using some of the disruptions caused by the pan-demic to explore innovations in the delivery of safe, high quality and equitable health care.”

Presenting the SHEA Lecture-ship is “an incredible honor,” Dr. Yokoe says. “When I look at the list of prior SHEA Lectureship recipi-ents, I’m pretty incredulous that my name has been added on. I’m also struck, though, by just how many of these amazing individuals who have achieved so much in the field of healthcare epidemiology, infec-tion prevention and antimicrobial stewardship I’ve had the privilege of working with and have been helped and mentored by during my career. This really highlights for me how incredibly fortunate I am to be part of such a supportive, dedicat-ed community.”

I was exposed to the enormous inequity with this burden of mortali-ty in young babies.” He supervised a 1998 trial in which the first infant in Africa received PCV. It took 12 years before that vaccine became widely available in South Africa. He says, “These long delays in between discovery and implemen-tation in rich countries have dra-matically changed. Although we’re really frustrated right now that the rollout of COVID vaccines has hap-pened around six months ahead of poor countries, that is a dramatic improvement of the status quo 20 years ago.”

SHEA LectureshipDeborah Yokoe, MD, MPH, will

explore the impact of COVID-19 on the health care community. She plans to include “some of the challenges and gaps that we were impacted by, some of the oppor-tunities that arose in the midst of or in same cases even because of the pandemic and some thoughts about using the lessons learned from these challenges and oppor-tunities as we look to the future.”

Dr. Yokoe, medical director of hospital epidemiology and infec-tion prevention at University of California San Francisco, believes “this will not be the last infectious disease crisis that we’ll need to contend with.” That means taking the lessons learned from this pan-demic to prepare for the next.

“This will require long-term in-vestments in prevention, detection and response to new and emerging infectious diseases at the global, national, local and health care facil-ity levels, expanded collaborations across disciplines and geographic regions and very thoughtful con-sideration of how we can translate what we’ve learned and are continu-ing to learn into concrete strategies to build a safer future,” she says.

LecturesContinued from page 24


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we were able to get a vaccine so fast? It would not have been possible without the decades of research we already had on mRNA vaccines. The R&D stood on the shoulders of decades of mRNA studies,” she said.

Other successes included a “thorough but rapid” review by the Food and Drug Administration as well as accomplishing tasks in tan-dem. Also quick: the impact of that development and review. Studies showed the Pfizer/BioNTech vac-cine to be 95 percent effective, with Moderna just a notch behind at 94 percent efficacy. The Janssen vac-cine was about 66 percent effective.

But efficacy rates don’t matter if people don’t get vaccinated. To date, more than 180 million people have been vaccinated in the U.S., and 55% of the U.S. population is fully vaccinated. For those over 18, two-thirds of the population are vaccinated; 83% of those over age 65 are. “While vaccine rates have come down, we are continuing to vaccinate 200,000 to 250,000 people per day,” she said.

About half the states have vacci-nated about 70% of their population with at least one dose. “That leaves half the states that have work to do,” she said. She’d like to see all states move to 80 or 90% vaccinated.

CDC and FDA are monitoring vaccine safety through numerous reporting systems. Dr. Walensky used the early issues with the J&J vaccine to demonstrate how these systems work. The passive report-ing system was used to “identify a rare and important link” between the J&J vaccine and thrombosis with thrombocytopenia syndrome.

A risk/benefit analysis showed

that TTS occurred more in women than in men and was particularly prevalent among women 18-49. Every million doses of the vac-cine given to women in that age group would avert 660 hospital-izations, 127 ICU admissions and 12 deaths. There might be 13 episodes of TTS. “Because of the comprehensive safety systems we had in place, we were able to demonstrate that the vaccine ben-efits were more than the risks,” Dr. Walensky said.

Myocarditis has a similar risk/benefit analysis, she said. Myocar-ditis is more common in men than women and more likely to occur with a second dose of an mRNA vaccine. But the risk of develop-ing myocarditis after receiving a vaccine was relatively small, about 45-56 for every 1 million shots. Meanwhile, those vaccines pre-vented 12,000 infections, 530 hos-pitalizations, 120 ICU admissions and three deaths.

The next hurdle is using data to show safety and efficacy in preg-nant women, who have a higher risk of severe complications if they acquire COVID-19. Dr. Walensky noted, “Compared to non-preg-nant women of reproductive age, they are less likely to be asymp-tomatic, more likely to be admitted to an ICU, require ventilation or need and ECMO.”

CDC’s v-safe, a smartphone app that logs symptoms, also asks about pregnancy status. For those who report pregnancy, CDC follows up with a phone call and screening questions. Pregnant people can en-roll and allow CDC to follow them throughout the pregnancy and into their child’s infancy. With more than 5,000 pregnant women enrolled, “we’ve been able to demonstrate there is no increased risk of spon-taneous abortion in pregnancy,”

says Dr. Walensky. But there are huge hurdles to

vaccination. About 30 percent of all pregnant women are vaccinat-ed and only about 15 percent of African American women who are pregnant.

COVID-19 has highlighted health disparities, Dr. Walensky said: “Early on in the pandemic, it became very clear that incidence, hospitalization and deaths were higher in those in ethnic and racial minorities.”

COVID-19 has reduced the overall life expectancy by 1.2 years, but in Hispanics and African Americans, it has fallen by three years and 2.9 years respectively. “This is urgent,” said Dr. Walensky. “We need to address these health disparities. We have the attention of the world, and this is our mo-ment to do so.”

CDC declared racism a serious public health threat, and Dr. Wal-ensky asked attendees to join her: “Confronting the impact of racism will not be easy, but I know that this will be successful if we work together. I know that I can rely on you to lean in and join me.”

She ended by thanking attend-ees. “Those who are listening to this are those who have done the basic science, the translational science and the clinical science. You have allowed us to get to where we are. You are the ones on the front lines. You are the public health champions who are helping to protect us, to protect our com-munities and the world,” she said.

WalenskyContinued from page 1

“Confronting the impact of racism will not be easy, but

I know that this will be successful if we work together.”

— Rochelle Walensky, MD, MPH, FIDSA


Miami Miller School of Medicine.“When you have a patient who

comes from a country where you are not familiar with the diseases, make sure to Google it or talk to a physician close by there,” Dr. Licht-enberger said. “Just admit that you

TropicsContinued from page 6

don’t know it all. Always doubt it. Go to where the people know. Be inquisitive and don’t just trust what the American literature says.”

As new diseases show up in previously unfamiliar locations, that is all the more important. “Known epidemiology has its limits,” Dr. Boggild said. “We get surprised all the time, so keep an open mind.”

Throughout in-depth discussion

of a wide range of cases, attendees were asked via poll for an initial di-agnosis. In most cases, more than two-thirds of those present made the correct diagnosis using the in-formation available. They also were able to hear the panelists discuss what additional tests they would order, what elements of information were missing and the best course of treatment for the disease. The

preparedness. “Much has been done, but there’s much more to do,” concluded Dr. Passaretti.

Dr. Chopra explored the impact of COVID-19 on antibiotic stew-ardship. “When COVID hit us, there was a concern for bacterial superinfection and the difficulties in distinguishing from community acquired pneumonia caused by bacteria when first arriving at a health care facility.”

Antibiotic use has increased during the pandemic, and rates of C. diff infections along with it. Dr. Chopra noted an increased risk of multidrug-resistant organisms as well: “We know that antibiotic resistance has gone up during the COVID-19 area.”

One of the main recommenda-tions is to optimize antibiotic use. “The mantra of right drug, right dose has to be followed,” said Dr. Chopra, adding, “We know that 70 percent of hospitalized COVID-19

AntibioticsContinued from page 20

patients received antibiotics. Stewardship efforts could be un-dermined because of high work-loads and shifting priorities.”

If you look at pandemics, there are factors that can reduce antimi-crobial resistance. Elective surgical interventions were postponed, while use of hand hygiene and PPE increased. Facilities also took steps to increase routine cleaning and cohort COVID-19 patients.

Dr. Srinivasan took on the topic of a “return to normal,” which may not be all it’s cracked up to be. Comparing pre-pandemic chal-lenges with today’s issues proves that looking back may not be a successful strategy.

Dr. Srinivasan explored dis-parities and staff shortages, both of which were issues before the pandemic. “What happens when you don’t have enough staff, infec-tion preventionists? They end up getting pulled away from the good work they are doing day to day and get pulled into COVID. All of the good prevention work that they were doing had to be crammed

into less than 25 percent of their time.”

Antibiotic stewardship programs also were strongly affected. Data collection and surveillance were “not nearly what we wanted.” Few nursing homes reported any health care associated infection data. Infection prevention and steward-ship programs were “largely based on educational and behavioral interventions that were completely dependent on people remembering to do the right thing every time.”

Making a case that returning to “normal” may not be best for health care, particularly around health care associated infections and stewardship, Dr. Srinivasan discussed the need to address disparities and to staff up infection prevention and stewardship so that when the next crisis comes, IP professionals aren’t pulled off im-portant day-to-day work of stew-ardship and infection prevention.

“We can build this whole thing back better,” he said. “We don’t want to see any health care setting left behind.”



HCP VaccinationContinued from page 22

authorized for use in the United States, vaccination rates and employment law to develop the statement.

Research shows that prior to the pandemic, rates of routine vacci-nation among health care providers were suboptimal. For flu vaccina-tion, when health care employers instituted policies of influenza vac-cination as a condition of employ-ment, compliance rose to 94.4% compared to 69.6% in organiza-tions without a requirement.

Over 33 million Americans have

contracted COVID-19, and more than 600,000 have died. The COVID-19 vaccines authorized for use in the U.S. have been found safe and effective in preventing infection and reducing transmis-sion. Studies have demonstrat-ed that the COVID-19 vaccines authorized for use in the U.S. also protect against variants and are particularly effective against se-vere disease, hospitalization and death.

Despite the positive data, there are still many health care profes-sionals who have declined to be vaccinated against COVID-19.

“Vaccinating the health care

workforce reduces the risk of transmission by protecting pa-tients, health care personnel and communities and maintains trust in health care providers and health care institutions,” Weber said.

The statement explains what to consider in developing a policy for COVID-19 vaccination as a con-dition of employment, including a thorough overview of current vaccines’ safety and efficacy, legal considerations, ways to engage stakeholders and improve vacci-nation rates before implementing a policy of vaccination as a condition of employment and advantages to having a fully vaccinated workforce.

IDWeek 2021 features more than 1,650 studies through virtual poster and oral abstract presen-

tations across all areas of infec-tious diseases. All 2021 oral and poster abstract presentations are available to view on demand.

To view abstract text and Pow-erPoint presentations with audio (for oral abstracts) or posters and audio (for posters), visit the Online Program. Logged-in users can “fa-

vorite” any abstract by clicking on the star next to its title. Abstracts you have designated as a favorite can be accessed from your per-sonal My Schedule page.

Have questions for the authors? Presenters that have chosen to participate in the chat-based question and answer functionality will be asked to respond to ques-tions Sept. 29-Oct. 3. Authors taking part in Q&As will have a

IDWeek Abstracts Available On Demand“Q&A and Discussion” button visi-ble at the bottom of their abstract. After clicking the button, you can use the “Questions” tab to ask questions of the author and the “Discussion” tab to discuss the abstract with other attendees. The Q&A and Discussion features will be open through Oct. 13.

All IDWeek 2021 abstracts will also be published this fall in Open Forum Infectious Diseases.

New evidence-based clinical guidelines on the man-agement of Clostridioides

difficile infection in adults have been developed by a multidisci-plinary panel representing IDSA and SHEA.

The guidelines provide recom-mendations for health care profes-sionals who care for adults with CDI, including specialists in infec-tious diseases, gastroenterologists,

hospitalists, pharmacists and any clinicians and health care providers caring for these patients. Updates include three recommendations on suggested treatments for patients with initial and recurring CDI ep-isodes, based on new data for fidaxomicin and for bezlotoxumab, a monoclonal antibody targeting toxin B produced by C. difficile.

The recommendations are grounded in a rigorous, systematic

IDSA and SHEA Release New Guidelines for Managing C. diff Infection

review of available evidence and an assessment of the benefits and harms of alternative care options. The panel adhered to the Grading of Recommendations Assessment, Development and Evaluation ap-proach to assess the certainty of the evidence and strength of rec-ommendations. The guidelines are intended to aid clinicians in deter-mining which treatments are best for individual patient scenarios.

https://academic.oup.com/cid/article-lookup/doi/10.1093/cid/ciab549

https://academic.oup.com/cid/article-lookup/doi/10.1093/cid/ciab549

https://www.gradeworkinggroup.org/




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The COVID-19 pandemic has highlighted the need for accurate and comprehensive pathogen detec-tion with genomic characterization. Variants may differ in pathogenicity, response to treatment, and vaccine effectiveness. Co-infections or sec-ondary infections are often difficult to diagnose with standard-of-care (SOC) tests but are known to affect disease severity and can be fatal.1) In addition, increasing prevalence of antimicrobial resistance (AMR) highlights the need for more effective detection and sur-veillance tools.

Precision Metagenomics identifies pathogens with excellent analytical sensitivity and concomitantly profiles AMR markers, providing results in all within a 24-hour turnaround time. Fastidious and slow-growing patho-

COVID-19: Accurate Detection and Genomic Profiling of Pathogens with Precision Metagenomics Can Improve Clinical Outcomes

gens are all included in the detection capabilities, providing an alternative to SOC tests.

The Potential of Precision Metagenomics

Examined in a research setting, the following case highlights the potential impact of Precision Metagenom-ics: A 81-year-old male presented with weakness of unknown etiology (initially SARS-CoV-2 PCR-negative). He worsened with evidence of noso-comial infection with SARS-CoV-2. An endotracheal aspirate (ETA) collected upon transfer to the medical ICU re-vealed “normal respiratory flora.”

Retrospective analysis of the same ETA specimen with Precision Metag-enomics resulted in the detection of SARS-CoV-2, Staphylococcus aureus

(mecA not detected), and Entero-coccus faecalis (vanA detected). The patient subsequently developed meth-icillin-susceptible S. aureus (MSSA) and vancomycin-resistant enterococ-cus (VRE) bacteremia. A subsequent SOC test of an ETA revealed only the presence of yeast. When analyzed with Precision Metagenomics, Can-dida auris was identified, which can be multi-drug resistant, cause candi-demia and has high mortality rates. Unfortunately, this patient successive-ly developed candidemia with Candi-da auris and expired. www.idbydna.com/idweek2021

References: 1) Musuuza JS et al. Prev-alence and outcomes of co-infection and superinfection with SARS-CoV-2 and other pathogens: a systemic review and me-ta-analysis. PLoS ONE. 2021: 16(4): 1-23.

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Cardiac implantable electronic device (CIED) infection is when an infection, either in the pocket or in the blood stream, has attached to the device or leads. A pocket infection begins either in the pocket (location on the chest where the generator is implanted) or in the blood stream and then attaches to the leads and can occur when the device is implanted or any time thereafter. Local symptoms of pocket infections are obvious indi-cators of a problem and may include redness of the skin, pain or tender-ness, swelling or warmth, drainage,

What Is CIED Infection?skin ulceration, and generator or lead erosion.1 A systemic infection may first develop elsewhere in the body—from a cut or wound that becomes infected and enters the bloodstream, eventually working its way to infect the leads. Systemic infections may be difficult to diagnose as 41% of device infections are not visible from the pocket and have a source other than the device.2 With over 31,000 patients affected in the US each year3, early identification of CIED infection is criti-cal to address this healthcare need.

Visit philips.com/deviceinfection

to learn more about different types of CIED infection.

1. Margey, R. et al. Contemporary man-agement of and outcomes from cardiac device related infections. Europace (2010) 12 (1): 64-70 first published online No-vember 11, 2009 doi:10.1093/ europace/eup362.

2. Voigt, Andrew, et al. Continued Rise in Rates of Cardiovascular Implantable Electronic Device Infections in the United States: Temporal Trends and Causative Insights. PACE Vol. 33, No. 4, 2010: 414-9.

3. Philips. (2020b). CIED Infection Treat-ment Inadequate Adherence to Guidelines. Data on File.

Dynavax is a commercial stage bio-pharmaceutical company developing and commercializing novel vaccines. The Company’s first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted],

is approved in the U.S. and the Euro-pean Union. Dynavax is also advanc-ing CpG 1018 adjuvant as a premier vaccine adjuvant through research collaborations and partnerships. Current collaborations are focused on

About Dynavaxadjuvanted vaccines for COVID-19, pertussis and universal influenza.

For more information, visit www.dynavax.com and follow the compa-ny on LinkedIn. For more information about HEPLISAV-B, visit heplisavb.com.

The ePlex® True Sample-to-Answer Solution® has a variety of features that can assist with transforming the landscape of microbiology lab testing to identify pathogens and resistance genes that cause bloodstream infec-tions, while also assisting the clinical team treating the patient with faster, more comprehensive information to help drive better therapeutic decision making and ultimately, better out-comes.

On September 23rd, as part of IDWeek’s 2021 Virtual Conference,

From One Institution to Another: What Can the ePlex BCID Panels Do for You?

GenMark sponsored a live Presen-tation Theater that showcased two important figures from the team at University of Alabama involved in the fight against bloodstream infections, Dr. Sixto Leal and Dr. Todd McCarty. Dr. Leal presented some background information on the ePlex system and panels, along with his laboratory findings, detailing the comprehensive coverage of the ePlex BCID Panels and how they perform against con-ventional microbiology methods. Dr. McCarty then described several

clinical case studies and retrospec-tive clinical outcomes based on the results of the study. Combined, these presentations are a great resource so others involved in the diagnosis of bloodstream infections can better understand the level of sensitivity and coverage of the ePlex BCID Panels and how they can contribute to im-proving patient outcomes.

The recorded presentation will be available for on-demand viewing through the IDWeek website through December 2021.

http://philips.com/deviceinfection

http://www.dynavax.com

http://www.dynavax.com

http://heplisavb.com




Respiratory viral infections (RVIs) are among the top five most com-mon types of infection in patients with immunodeficiency (primary [PI] and secondary) and pose a substan-tial clinical burden.1 The majority of RVIs precede bacterial infections or present as co-infections.2 The risk is related to the severity of the immunodeficiency,3 where 89% of HSCT recipients experience ≥1 RVI3 and 61% of lung transplant patients experience ≥1 RVI.4

PI patients are more vulnerable to infections and more likely to suffer complications from these infec-tions.1 As patients with PI lack a properly functioning immune sys-tem, they typically receive monthly, outpatient infusions of IVIG therapy.1 Without exogenous antibody im-mune support, these patients would

be susceptible to a wide variety of infectious diseases.

ADMA Biologics is an end-to-end commercial biopharmaceutical com-pany committed to manufacturing, marketing and developing specialty plasma-derived products for the prevention and treatment of infectious diseases in the immune compromised and other patients at risk for infection. Our devotion to these underserved populations fuels us, and our hands-on approach to production and devel-opment sets us apart.

ADMA currently manufactures and markets three United States Food and Drug Administration (FDA) approved plasma-derived biolog-ics for the treatment of immune deficiencies and the prevention of certain infectious diseases:

• ASCENIV™ (immune globu-

lin intravenous, human – slra 10% liquid) for the treatment of primary humoral immunodeficiency (PI);

• BIVIGAM® (immune globulin in-travenous, human) for the treatment of PI; and

• NABI-HB® (hepatitis B immune globulin, human) to provide en-hanced immunity against the hepati-tis B virus.

Visit our virtual exhibit space to learn more about managing patients at risk for infection and to chat with us live!

Learn more at www.admabiolog-ics.com.

References: 1. Jesenak M, et al. Front Pediatr. 2014;25(2):77. 2. Wiegers HMG, et al. BMC Infect Dis. 2019;19(1):938. 3. Piñana JL, et al. Biol Blood Marrow Trans-plant. 2018;24(3):563-570. 4. Bridevaux PO, et al. Thorax. 2014;69(1):32-38.

Groundbreaking Immunotechnology, One Connection at a Time

The Certification Board of Infec-tion Control and Epidemiology, Inc. (CBIC) is responsible for developing, implementing and administering the only certification in infection preven-tion and control that is accredited by the National Commission for Certifying Agencies (NCCA). CBIC is considered the industry leader in providing a standardized measure-ment of essential knowledge needed for individuals practicing infection prevention and control. The CIC® cre-dential is awarded to healthcare pro-fessionals who have demonstrated a mastery of knowledge in the field.

Reliability and validity of the CIC® examination is ensured through the

test development process. CBIC follows best practices for test de-velopment and cut score as deter-mined by the Institute for Creden-tialing Excellence (I.C.E). CBIC is committed to routinely performing a Practice Analysis to ensure that the examination accurately reflects the responsibilities and required knowl-edge of those practicing in the field of infection prevention and control.

The most recent Practice Analysis was completed in 2020; over 1,400 IPs from around the world partici-pated! Their responses were used to develop new test specifications, forming an updated exam blueprint. Test Committee volunteers have

been working diligently over the past year to create content for the newly updated exam. With the conclu-sion of the beta testing period, new passing standards will be created and validated. The CIC® examina-tion will not be available during this crucial process. Applications reopen for the examination in January 2022.

The CIC® certification is held by over 8,000 infection prevention and control professionals working in hospitals, long-term care facilities, ambulatory care centers, and other healthcare and public health set-tings throughout the world. For more information on becoming certified visit www.cbic.org.

Learn More about CIC® Certification from CBIC®

http://www.admabiologics.com

http://www.admabiologics.com

http://www.cbic.org




The growing challenges of a limit-ed number of oral treatment options for complicated urinary tract infec-tion (cUTI) and acute pyelonephritis (AP) due to antibiotic resistance place undue burden on both pa-tients and the healthcare system, in terms of recurrent infections, hospi-talizations, and cost.1,2

Despite the reduction in the se-verity of UTI patients, there has been an increase in hospitalizations.2 A study of hospital admissions across 250 US hospitals (2013-2018) found that 1 in 5 patients admitted with a cUTI were low acuity, suggest-ing potentially avoidable hospi-talization.3 The increasing rates of resistance amongst uropathogens and rise in hospitalization for UTI

It’s Time to Address Treatment Challenges in cUTI and Evolve the Treatment Approach

suggest that alternative oral options may be necessary for certain pa-tients to enhance the ability to treat effectively and safely in the commu-nity.2

Are current oral options for cUTI keeping up with rising resistance? With roughly 1 in 8 cUTI patients infected with a pathogen resistant to at least 3 orally available antibiotic classes, including fluoroquinolones, trimethoprim/sulfamethoxazole, and third-generation cephalosporins, treating cUTI is increasingly chal-lenging.4

Antibiotic resistance is a leading concern when it comes to manag-ing cUTI in an outpatient setting.5 Spero Therapeutics is committed to evolving cUTI management through

the identification, development, and commercialization of novel treat-ments for gram-negative pathogens to address the most urgent unmet needs of patients while aligning with key antibiotic stewardship princi-ples. Find out more at sperothera-peutics.com.

Explore how the current cUTI treatment gap burdens certain patients and clinicians at cUTIevolu-tion.com.

References1. Carreno J, et al. Open Forum Infect

Dis. 2019. 2. Simmering J, et al. Open Forum Infec Dis. 2017. 3. Lodise T, et al. Am J Infect Control. 2021;S0196-6553(21)00382-5. 4. Zilberberg M, et al. BMC Infect Dis. 2021;21. 5. Critchley I, et al. PLoS ONE. 2019;14(12).

Join Tufik R. Assad (MD, MSCI) for an IDWeek Presentation The-ater titled “The Clinical Utility of the BioFire® FilmArray® Pneumonia (PN) Panel and Procalcitonin to Aid in Pneumonia Diagnosis.” Dr. Assad will discuss how the BioFire Pneu-monia Panel has aided in the rapid identification of a causative patho-gen in several cases of pneumonia.

The presentation took place on Thursday, September 23, and is now available on-demand.

In about an hour, the BioFire Pneumonia Panel can detect 33 clinically relevant targets, including the most common causes of pneu-monia and associated antimicro-bial resistance genes. The BioFire

Pneumonia Panel can test sputum samples (including endotracheal aspirate) and bronchoalveolar la-vage samples (including mini-BAL). The panel provides semi-quantita-tive results for 15 bacteria, which may help determine whether an organism is a colonizer or possi-bly something more serious. The BioFire Pneumonia Panel has the potential to significantly improve time to result and allow treating physicians to put patients on the right therapy quickly.

BioFire Diagnostics offers syn-dromic infectious disease diag-nostic solutions with several as-say-specific reagent panels. Each panel provides the ability to detect

and identify a broad grouping of probable pathogens in a single, rapid PCR-based test. The syn-dromic approach provides fast and accurate diagnostic results, max-imizing the chances of finding out what’s making a patient sick and helping physicians quickly provide appropriate treatment. BioFire currently offers diagnostic panels that tackle five infectious disease syndromes: respiratory infections, gastrointestinal infections, blood stream infections, meningitis/en-cephalitis, and pneumonia.

To learn more about BioFire’s rapid diagnostic solutions for pneu-monia and other clinical syndromes, visit biofiredx.com.

BioFire Pneumonia Panel

http://cUTIevolution.com

http://cUTIevolution.com

http://biofiredx.com

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