The workshop included members of the public, academics, and representatives of the pharmaceutical industry to discuss development of new medicines for preventing HAIs and antibiotic resistance.
With health care-associated infections (HAIs) costing so much in emotional, physical, and financial ways, the public is asking what can be done. Therefore, the search for pathogen-directed products used to prevent HAIs, evidence for decolonization, and new drugs to prevent antimicrobial resistance are topics which need to be discussed and researched.
To review these topics and others with the public, the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) cosponsored the public virtual workshop titled, “Drug Development Considerations for the Prevention of Healthcare-Associated Infections” on Aug 30, 2022. Each of the presenter’s presentation slides are available on the website.
To get an inside look at the workshop, John A. Jernigan, MD, MS, and Michael Craig, MPP answered Infection Control Today®’s (ICT®’s) questions about the CDC and FDA Public Workshop and their own presentations.
Infection Control Today® (ICT®): Would you please give me a bit of your professional background for ICT®’s readers?
John A. Jernigan, MD, MS: John Jernigan serves as Chief, Epidemiology Research and Innovations Branch, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention. He has 30 years of experience in clinical infectious diseases and health care epidemiology. After medical school and residency at Vanderbilt University, Dr. Jernigan completed an Infectious Diseases fellowship at the University of Virginia, where he also earned a master’s degree in epidemiology. He served for 6 years as hospital epidemiologist at Emory University before joining CDC in 2001. He has served on the board of directors for both the Association for Professionals in Infection Control and Epidemiology (APIC) and the Society for Healthcare Epidemiology of America (SHEA), was named the SHEA Investigator awardee in 2005, and served as president of SHEA in 2013. He has over 140 peer reviewed original research publications related to prevention of health care-associated infections and antibiotic resistance.
Michael Craig, MPP: Since 2016, Michael Craig, MPP, has served as the director of CDC’s cross-cutting antimicrobial resistance activities. He is one of the Ex Officio Members representing CDC on the President’s Advisory Committee for Combating Antibiotic-Resistant Bacteria. He also works closely with leadership within the US Department of Health and Human Services to align public health activities related to antimicrobial resistance across multiple federal agencies.
ICT®: Please give an overview of the CDC & FDA Public Workshop.
JJ: The Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) co-sponsored a public virtual workshop involving members of the public, academics, and representatives of the pharmaceutical industry to discuss the current state of development new medicines for preventing health care-associated infections and antibiotic resistance. The workshop included presentations reviewing the evidence supporting decolonization and pathogen reduction (in colonized patients) as a strategy to prevent infection and transmission of antimicrobial-resistant health care-associated pathogens, and challenges and potential approaches to drug development and registration of such products.
ICT®: What did you cover during your portion of the workshop? Would you give ICT®’s readers the most important takeaways?
JJ: I discussed the rationale for decolonization as an antibiotic resistance prevention strategy. I reviewed how colonization by antibiotic resistant pathogens increases risk of infection and increases risk of transmission to others, and is therefore an important driver of antibiotic resistance, particularly in health care. For these reasons, reducing colonization by resistant organisms may be a potent prevention strategy. Furthermore, treating people who are colonized with resistant organisms can reduce risk not only to those who are treated, but also to the surrounding population by decreasing shedding/transmission (we refer to this as indirect benefit of treatment). Mathematical modeling suggest that use of effective decolonizing agents will save more lives through indirect benefit (preventing transmission) than will agents that treat infections. [Jernigan’s presentation slides can be found here.]
MC: Data show that there are 5-10 times as many patients colonized with dangerous pathogens than patients who actually become infected. That’s a huge untapped opportunity for public health prevention efforts. However, health care providers and public health experts need more approved, regulated tools that help prevent that colonization from turning into an infection or spreading to others—instead, we have to wait to treat it and hope the available drugs will be effective. That said, we know that antibiotics and antifungals that are approved to treat infections are sometimes being used “off label” to prevent colonization and subsequent infections. We need development pathways that could allow for new and existing products to be approved for prevention. This could help reduce the pressure for new drugs, prolong the life of the antibiotics and antifungals we have today, and ideally benefit an individual and a larger population, such as residents living in the same part of a long-term care facility. In the US alone, these prevention products have the potential to benefit the 5 million patients admitted to ICUs each year, the 1.3 million nursing home residents, and the 2.8 million antimicrobial-resistant infections that occur annually—and many more! We expect there will be many challenges as scientists and regulators work to help public health close this prevention gap, but certainly these patients deserve that effort from us. (Craig’s presentation slides are here.)
ICT®: Is there anything that you would like to add to what you didn’t get to cover or wish the workshop would have covered?
JJ: We’re hoping that the discussions started during the workshop can encourage more research and development for agents designed to reduce or eliminate colonization by pathogens, and also spark conversation about a roadmap for regulatory approval for such agents. We think there is still a lot of wisdom in the old adage, "An ounce of prevention is worth a pound of cure."
MC: Microbes (germs) are resilient and constantly evolve. We know that antibiotics can save lives from dangerous infections; however, they cannot be the only tool in our toolbox. If a patient has an infection or is colonized by one of these pathogens, CDC and health departments and clinicians have a comprehensive approach to rapidly detect their spread, through the AR Lab Network. Once the threat is identified, infection prevention and control begins can contain the threats—however, it has to be perfectly used consistently and correctly by all health care staff in order to be most effective. Our patient safety toolbox is missing a critical tool: one that will help us stop infections before they happen and stop transmission once identified. Decolonization. The best infection is the one that never happens.
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