Illustration of C. difficile bacteria. (image courtesy of CDC/Jennifer Oosthuizen)
Vanderbilt Health researchers are enrolling hundreds of adult patients age 65 and older for a study of people who have not had a C. difficile infection but are at increased risk due to taking antibiotics in the past three months, having 10 or more health care visits in the past year, being hospitalized at least once, having two emergency rooms visits, or are scheduled to be hospitalized/have elective surgery.
C. difficile (C. diff) is a highly contagious bacteria that infects the colon, causing severe diarrhea, abdominal pain and fever. It is typically treated with antibiotics (vancomycin or fidaxomicin) and can last weeks.
Participants in the BEETHOVEN study will be randomized to receive two C. difficile vaccine doses six months apart, or a placebo, to learn if an investigational vaccine is safe and can help prevent C. difficile infection in people age 65 and older.
A similar study was conducted a few years ago and showed significant reductions in C. difficile among certain high-risk populations, according to study leader C. Buddy Creech, MD, MPH, director of the Vanderbilt Vaccine Research Program.
“Now more than ever, we recognize the importance of gut health,” Creech said. “Unfortunately, many patients have major changes to gut health because of surgery, antibiotics and exposure to the health care system, which can lead to germs like C. difficile taking over and causing serious health problems.
“This study will be an important next step in preventing what has become one of the most common infections that we see in older adults and children,” he said.
The study could last up to three and a half years; there will be three in-person visits and three phone calls in the first 18 months, followed by one annual visit until the study ends. There is no cost to enroll, and participants will be paid for completing some study-related activities. Health insurance is not required to participate.
“All current treatments for infection from C. difficile are reactive — treating them after they develop symptoms and when they may already have complications,” said Maribeth Nicholson, MD, MPH, associate professor of Pediatrics in the Division of Pediatric Gastroenterology, Hepatology, and Nutrition at Monroe Carell Jr. Children’s Hospital at Vanderbilt.
“The ability to prevent this important pathogen before it causes severe harm, particularly among those at highest risk, would dramatically improve our patients’ lives and transform the field,” said Nicholson, who is leading the study with Creech.
The Vanderbilt Vaccine Research Program was founded in 2001 by prominent Vanderbilt vaccinologist Kathryn Edwards, MD, now a professor emerita of Pediatrics.
