University of Louisville Accepting Patients in Study of C. diff Vaccine

The University of Louisville (U of L) has been selected as a study site for a clinical trial researching a vaccine to prevent infection from a bacterium that primarily affects older patients in hospitals or long-term care facilities who also have taken broad-spectrum antibiotics.

Clostridium difficile is a spore-forming bacterium that is emerging as a leading cause of potentially deadly healthcare-associated infections. Toxins from C. diff cause gastrointestinal disease, with symptoms ranging from mild diarrhea to life-threatening colitis, often including dehydration and abdominal pain. In the United States, 350,000 people are hospitalized every year due to C. diff infection, and 77 percent of the cases occur in people age 50 or older.

The Phase III Cdiffense trial at U of L is led by Julio Ramirez, MD, and Ruth Carrico, PhD, RN, the medical and clinical directors of the Vaccine and International Travel Center in the Department of Medicines Division of Infectious Diseases. U of L is one of 200 trial sites in the United States and 16 other countries participating in the randomized, observer-blind, placebo-controlled study.

Volunteers eligible for the study should be age 50 or older and are either:
 Planning an upcoming surgical procedure that will likely keep them in the hospital for at least 72 hours; or,
 Have had at least two hospital stays, each lasting more than 72 hours, and have received systemic antibiotics in the past year.

For additional information about the study and enrolling in the trial, call (502) 562-2822 or visit the National Institutes of Health clinical trials website at ClinicalTrials.gov, using the trial identifier number, NCT01887912.

While most healthcare-associated infections are declining, C. diff continues to cause life-threatening infections seen in hospitals and long-term facilities worldwide, raising concerns about how to control it and prevent transmission, Carrico says.

New strains of C. diff are emerging that are difficult to manage, and infection from C. diff has become more frequent, severe and difficult to treat in recent years, says Ramirez, who is chief of infectious diseases at U of L. Vaccination could be an efficacious, cost-effective and welcome public health measure to protect people from this terrible infection.

The trial is sponsored by Sanofi Pasteur, the vaccines division of Sanofi. In 2010, the FDA granted fast-track designation to the investigational C. diff vaccine being developed by Sanofi Pasteur. The fast-track program of the FDA facilitates development and expedites review of new drugs and vaccines that are intended to treat or prevent serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.