Riverside’s Center for Excellence in Aging and Lifelong Health Participates in Phase III Trial of Investigational Vaccine for Prevention of Clostridium Difficile

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Volunteers needed for study of vaccine to prevent leading cause of healthcare-associated infections.

Riverside’s Center for Excellence in Aging and Lifelong Health (RCEALH) announced this week that it is participating in a clinical study to evaluate the safety, immunogenicity 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.

Riverside’s Center for Excellence in Aging and Lifelong Health 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 72 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 Dr. Paul E. Evans III of RCEALH.

“Vaccination could be an efficacious, cost-effective and important public health measure to protect individuals from C. diff.”

In 2010, the U.S. Food and Drug Administration (FDA) granted fast-track designation to the investigational C. diff vaccine candidate being developed by Sanofi Pasteur.

The fast-track program of the FDA is designed to facilitate the development and expedite the review of new investigational drugs and vaccines that are intended to treat or prevent serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.

For more information about the Cdiffense Phase III clinical trial, please contact the Riverside Center for Excellence in Aging and Lifelong Health study coordination at 757-220-4751, or visit http://www.Cdiffense.org.

About C. diff

Clostridium difficile (C. diff) is a potentially life-threatening, spore-forming bacterium that causes intestinal disease. According to the Centers for Disease Control and Prevention (CDC), 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-hospitalizations and longer hospital stays.

About the Riverside Center for Excellence in Aging and Lifelong Health

The Riverside Center for Excellence in Aging is a non-profit organization dedicated to improving care and better meeting the needs of a growing older adult population. This is accomplished by integrating aging research with clinical capabilities to develop innovative programs and services that can be applied and sustained by Riverside Health System, the community, and other providers of aging-related services. Riverside CEALH’s services include caregiver support, geriatric assessments, driver rehabilitation, aging research and clinical trials.

Dr. Paul E. Evans III is a Board Certified physician specializing in Family Practice and Geriatrics. He has been practicing with RCEALH for five years. Dr. Evans earned his degree from the University Of Connecticut School Of Medicine and was trained at the Riverside Family Practice Program. The clinical trial facility is located at 3901 Treyburn Drive, Suite 100, Williamsburg, VA.

For more information, please call 757-220-4751 or email the Research Coordinator, Keri Allen, at kallen(at)excellenceinaging(dot)org.

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Stephanie Heinatz
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since: 08/2012
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