Jacksonville Center for Clinical Research Participates in Phase III Trial of Investigational Vaccine for Prevention of Clostridium difficile (C. diff)
Cdiffense trial to evaluate vaccine against a leading cause
of life-threatening, healthcare-associated infections worldwide
Jacksonville, FL December 5, 2013 – Jacksonville Center for Clinical Research (JCCR) announced today that it is participating in a clinical study to evaluate the safety, immunogenicity and efficacy of an investigational vaccine for the prevention of primary symptomatic Clostridium difficile (C. diff) infection (CDI). C. diff is a potentially life-threatening, spore-forming bacterium that causes intestinal disease. While most types of healthcare-associated infections (HAIs) are declining, C. diff is emerging as a leading cause of life-threatening, HAIs worldwide. The infection poses the greatest danger for older adults in hospitals or long-term care facilities who take broad-spectrum antibiotics.[i]
JCCR joins more than 200 sites across 17 countries from around the world in the Cdiffense clinical trial, a Phase III randomized, observer-blind, placebo-controlled study. Volunteers for the study should be age 50 or older and planning an upcoming hospitalization of more than 72 hours for a surgical procedure. People in this age group who have had at least two hospital stays, each lasting more than 72 hours, and have received systemic antibiotics in the past year are also eligible.
“With the emergence of difficult-to-manage strains of C. diff, CDI has become more frequent, more severe and more difficult to treat in recent years, raising concerns about how to control it and prevent transmission,” explained Alpa Patel, MD of JCCR. “Vaccination could be an efficacious, cost-effective and important public-health measure to protect individuals from C. diff.”
In 2010, the U.S. Food and Drug Administration (FDA) granted fast-track designation to the investigational C. diff vaccine candidate being developed by Sanofi Pasteur. The fast-track program of the FDA is designed to facilitate the development and expedite the review of new investigational drugs and vaccines that are intended to treat or prevent serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.
For more information about the Cdiffense Phase III trial, please contact the JCCR study coordinator at (904) 730-0166, or visit www.Cdiffense.org.
About C. diff
Clostridium difficile (C. diff) is a potentially life-threatening, spore-forming bacterium that causes intestinal disease. According to the Centers for Disease Control and Prevention (CDC), approximately 500,000 Americans are infected with C. diff,[ii] and at least 14,000 fatalities are attributed to C. diff each year.[iii] The risk of C. diff increases with age, antibiotic treatment and time spent in hospitals or nursing homes, where multiple cases can lead to outbreaks.1 A main source of C. diff is infected patients who release spores into the environment that can then infect other people. When antibiotics disrupt the gut’s normal flora and a person has ingested C. diff spores, the C. diff bacteria multiply and release potent toxins that can damage a person’s intestinal lining and cause C. diff disease.[iv]
About Alpa Patel, MD
Dr. Alpa Patel is a Board Certified physician specializing in Internal Medicine. She has been practicing with JCCR for five years. Dr. Patel earned her degree from The University of Florida College of Medicine, Gainesville and was trained at Shands Hospital Department of Internal Medicine, Jacksonville.
The clinical trial facility is located at 4085 University Blvd. S., Ste. 1; Jacksonville, FL 32216 For more information, please call (904) 730-0166 or www.jaxresearch.com
[i] Centers for Disease Control and Prevention. Frequently Asked Questions about Clostridium difficile for Healthcare Providers. Centers for Disease Control and Prevention. http://www.cdc.gov/HAI/organisms/cdiff/Cdiff_faqs_HCP.html. Last Updated March 6, 2013. Accessed May 30, 2013.
[ii] Rohlke F and Stollman N. Fecal microbiota transplantation in relapsing Clostridium difficile infection. Therap Adv Gastroenterol. 2012 November; 5(6): 403–420. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3491681/#bibr37-1756283X12453637. Accessed May 30, 2013.
[iii] Centers for Disease Control and Prevention. Clostridium difficile Infection. Centers for Disease Control and Prevention. http://www.cdc.gov/hai/organisms/cdiff/cdiff_infect.html. Last Updated March 1, 2013. Accessed May 30, 2013.
[iv] Delmee M and Warny M. (1995). Clostridium difficile colitis: recent therapeutical and immunologicalconsiderations. Acta Gastroenterol Belg, 58 (3-4), p. 313-317.