Rochester Hospitals Enrolling for Investigational C. diff Vaccine Trial

Faculty in the University of Rochester Medical Center’s Infectious Disease Division announced today that they’ll head up local trial sites for an international study evaluating the safety and effectiveness of an investigational vaccine aimed at blocking Clostridium difficile infections.

The hardy bacteria and its tough-to-kill spores, known by the nickname C. diff, vex hospitals, long-term care facilities and communities nationwide. The greatest burden typically falls upon older patients undergoing a course of antibiotics, which disrupt the gut’s normal bacterial flora, allowing C. diff to multiply furiously and leak toxins that ravage a patient’s intestinal lining. The resulting bowel inflammation and diarrhea can be life-threatening, delaying a patient’s discharge by days and pushing his or her complete recovery back by months.

“With the emergence of difficult-to-manage strains of C. diff, these infections have become more frequent, more severe and more difficult to treat in recent years,” said URMC’s Chief of Infectious Disease John Treanor, M.D., who is serving as co-primary investigator together with Ann Falsey, M.D., also on faculty at URMC. “Vaccination could prove to be an important way to control these infections and improve health care for everyone.”

“The financial costs can be painful, too, sometimes piling tens of thousands of dollars on top of an admission,” added Falsey. “And at a time when most types of healthcare-associated infections are declining, C. diff is certainly swimming against current, emerging as a leader."

Treanor, who practices at Strong Memorial Hospital, will enroll vaccine study subjects seen there and at affiliate Highland Hospital; Falsey, who practices at Rochester General Hospital, will enroll subjects being treated there.

The Centers for Disease Control and Prevention reports that, each year, nearly 500,000 Americans are infected with C. diff. Also annually, at least 14,000 fatalities are attributed to the bacteria.

Studying a Candidate Vaccine

URMC joins more than 200 sites across 17 countries in the Cdiffense clinical trial, a Phase III randomized, observer-blind, placebo-controlled study.

Interested volunteers should be 50 or older and planning an upcoming surgical procedure that requires hospitalization lasting more than 72 hours. Patients 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. 

In 2010, the U.S. Food and Drug Administration granted “fast-track” designation to  the investigational C. diff vaccine candidate being developed by Sanofi Pasteur. The fast-track program is designed to promote the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions—and that demonstrate strong potential to address unmet medical needs.

For more information about the Cdiffense Phase III clinical trial, please call 273-3990 (for patients seen at Strong Memorial and Highland) or 922-5944for patients treated at Rochester General Hospital, or visit www.Cdiffense.org.