Public Workshop on Emerging Clostridial Disease
May 11, 2006, Atlanta, Georgia

On May 11, 2006, the FDA, the CDC and the NIH held a joint workshop on emerging clostridial diseases (summary and other documents below).

 

The primary goal of this public workshop was to bring together scientific and public health experts to identify research needs and priorities in order to enable progress in understanding the virulence, pathogenesis, host factors, and nonantimicrobial risk factors contributing to reports of morbidity and mortality associated with Clostridium sordellii and Clostridium difficile.  These infections include cases and clusters of C. sordellii toxic shock syndrome following treatment with mifepristone and misoprostol, C. sordellii sepsis associated with skin grafts, and rapidly fatal toxin-mediated cases of community-associated C. difficile infection.

 

Three panels, consisting of medical and/or public health representatives from federal government, state governments, and academia, presented data and discussed a number of the complex issues surrounding these two related anaerobic bacteria.

 

There appeared to be a broad consensus that additional research is necessary to improve the clinical understanding of both C. sordellii and C. difficile.  Participants also stressed that surveillance and communication efforts should continue to be refined and focused on enhancing the epidemiological data about, and awareness among clinicians of both diseases.  The workshop served as an important first step in advancing the understanding of some of the most critical underlying questions surrounding mifepristone, C. sordellii-related deaths, and any potential association between the two.  The workshop also identified that additional important questions remain, for example, the role of toxin production and potential antibiotic use in association with mifepristone.  FDA is committed to continuing to work with others, both within and outside of the federal government, to improve the knowledge of these dangerous diseases and the public health concerns they raise. 

• Agenda (5/5/2006)
• Instructions for Registered Attendees (5/5/2006)
• Committee Members (5/15/2006)
• Federal Register Notice of Public Workshop [HTML] or [PDF]
• Summary of Proceedings (posted 6/20/2006, revised 6/22/2006)
• Meeting Transcript (posted 6/20/2006)
• Presentations
  • Toxins of Clostridium difficile [PDF], Jimmy D. Ballard, Ph.D., University of Oklahoma
  • Initiatives at the State Level and Performance Characteristics of Optimal Surveillance Systems [PDF], Jeffrey Engel, M.D., North Carolina State Epidemiologist,NC Division of Public Health
  • Clostridium sordellii toxic shock syndrome following medical abortion [PDF], Marc Fischer, M.D., M.P.H., CDC
  • Clostridium difficile-Associated Disease (CDAD): Clinical Aspects [PDF], Dale N. Gerding, M.D., Hines VA Hospital, Loyola University Stritch Medical School
  • Clostridium difficile: Pathogenesis and Host Response [PDF], Ciar?n P Kelly, MD, Beth Israel Deaconess Medical Center, Harvard Medical School
  • Surveillance for Disease and Sources of Infection: Initiatives at the Federal Level and International [PDF], L. Clifford McDonald, M.D., CDC
  • An OB/GYN View of Early Medical Termination and Clostridium sordellii Infection [PDF], James A. McGregor, M.D.C.M., Univ. of Southern California
  • Pathophysiology of Mifepristone-Induced Septic Shock Due to Clostridium sordellii [PDF], Ralph Miech, M.D., Brown University
  • Regulation of Clostridium difficile: Toxin Gene Expression [PDF], Abraham L. Sonenshein, Tufts University School of Medicine
  • Bacterial Toxin Repression of Nuclear Hormone Receptors: Host-Pathogen-Hormone Interactions and Implications for Therapy [PDF], Esther M. Sternberg, M.D., NIH
  • Clostridium sordellii: Clinical Settings, Diagnostic Clues and Pathogenic Mechanisms [PDF], Dennis L. Stevens, M.D., Ph.D., Veterans Affairs Medical Center, Boise, ID and University of Washington School of Medicine

Comments:  Written or electronic comments will be accepted after the workshop until June 15, 2006. The administrative record of the workshop will remain open until June 15, 2006.

Send Comments:

• Mailing Address:
  • Division of Dockets Management (HFA-305)
    Food and Drug Administration
    5630 Fishers Lane, Room 1061
    Rockville, Maryland 20852
• Email Address:  FDADockets@fda.hhs.gov
• Internet:  Dockets Open for Comment

Transcripts of the workshop will be available for review at the Division of Dockets Management and on the Internet on the Dockets Management Site approximately 30 days after the workshop.

For further information, write or ask to speak with the Workshop Coordinator at:

Office of Executive Programs (HFD-006)
Center for Drug Evaluation and Research
Food and Drug Administration
5515 Security Lane
Rockville , Maryland   20852
301-594-6779