Allegheny General Hospital Opens Trial of Investigational Vaccine for Prevention of Leading Cause of Healthcare-Associated Infections, Clostridium difficile

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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).

Allegheny General Hospital

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

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-hospitalizations and longer hospital stays.

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 AGH’s study coordinator at 412.359.3095 or visit http://www.Cdiffense.org.

About Allegheny Health Network
Allegheny Health Network, part of Highmark Health, is an integrated healthcare delivery system serving the Western Pennsylvania region. The Network is comprised of eight hospitals, including its flagship academic medical center Allegheny General Hospital, Allegheny Valley Hospital, Canonsburg Hospital, Forbes Hospital, Jefferson Hospital, Saint Vincent Hospital, Westfield Memorial Hospital and West Penn Hospital; a research institute; Health + Wellness Pavilions; an employed physician organization, home and community based health services and a group purchasing organization. The Network employs approximately 17,500 people and has more than 2,100 physicians on its medical staff. The Network also serves as a clinical campus for Temple University School of Medicine, Drexel University College of Medicine and the Lake Erie College of Osteopathic Medicine.

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Jennifer Davis
Allegheny Health Network
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