LOUISVILLE, Ky. – The University of Louisville 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, called “C. diff,” is a spore-forming bacterium that is emerging as a leading cause of potentially deadly health care-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 UofL is led by Julio Ramirez, M.D., and Ruth Carrico, Ph.D., R.N., the medical and clinical directors of the Vaccine and International Travel Center in the Department of Medicine’s Division of Infectious Diseases. UofL 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: