The Definitive Blog

Allegheny General Hospital Opens Trial of Investigational Vaccine

Allegheny General Hospital (AGH), part of Allegheny Health Network, today announced that it will enroll patients in a clinical study to evaluate the safety and efficacy of an investigational vaccine for the prevention of primary symptomatic Clostridium difficile infection (CDI).

Clostridium difficile (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.

Allegheny General joins more than 200 sites across 17 countries 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 24 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 Zaw Min, MD, an infectious disease specialist who is serving as principal investigator of the trial at AGH. “Vaccination could be an efficacious, cost-effective and important public health measure to protect individuals from C. diff.”

According to the Centers for Disease Control and Prevention, approximately 500,000 Americans are infected with C. diff, and at least 14,000 fatalities are attributed to C. diff each year.

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. A main source of C. diff is infected patients who release spores into the environment that can then infect other patients.

More than 50 percent of hospital patients test positive for colonized C. diff organisms but do not exhibit any clinical symptoms. When antibiotics disrupt the gut’s normal flora and a person has ingested C. diff spores, the C. diff bacteria multiplies and releases potent toxins that can damage a patient’s intestinal lining and cause C. diff disease. Approximately 20 to 30 percent of patients experience recurrences of C. diff infections, which result in re-
Napper holds a Bachelor of Science degree in Healthcare Management from Park College in Parkville, MO, and a Master of Business Administration degree from Embry-Riddle Aeronautical University in Daytona Beach, FL. In addition, he graduated from the Academy of Health Sciences, Fort Sam in Houston, TX as an LPN.

October 13, 2015