Clinical trials are being conducted in Williamsburg for a vaccine against one of the most common causes of hospital-acquired infection in North America and Europe
The Center for Excellence in Aging and Geriatric Health in Williamsburg announced that it is participating in a phase II clinical study of an investigational vaccine for primary prevention of Clostridium difficile infection (CDI). The trial being held across the United States is focused on evaluating prevention of the first episode of CDI in at-risk individuals, which includes adults with imminent hospitalization or current or impending residence in a long-term care or rehabilitation facility.
The incidence of this infection has increased significantly in recent years in both North America and Europe. CDI-related treatments in these two regions of the world are estimated to be costing more than $7 billion a year. The recent emergence and spread of a hyper-virulent strain of C. difficile further highlights the importance of preventing CDI.
C. difficile is present worldwide and has become the most frequent hospital-acquired infection in the U.S., Europe, and Canada. Standard treatment of C. difficile infection involves the use of antibiotics. The trial in which Dr. Paul Evans, Riverside Medical Group, is participating includes an investigational CDI preventative vaccine being developed by Sanofi Pasteur.
The U.S. Food and Drug Administration recently granted fast-track designation to Sanofi Pasteur’s investigational Clostridium difficile vaccine candidate. The fast-track program of the FDA is designed to facilitate the development and expedite the review of new drugs and vaccines that are intended to treat or prevent serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.
About C. difficile
C. difficile is an anaerobic spore-forming bacterium, present asymptomatically in approximately 60 percent of infants and approximately 3 percent of healthy adults. It belongs to the Clostridium family of bacteria, which also includes C. tetani (tetanus) and C. botulinum (botulism). The C. difficile bacteria produce two potent toxins: A and B. When the natural microbial flora of the gut is disturbed, usually as a result of antibiotic treatment for other illnesses, and a patient is exposed to C. difficile spores, the bacteria can multiply and release the two toxins, which cause a broad range of gastrointestinal symptoms in humans known collectively as CDI.
It is estimated that there are about 500,000 cases of CDI in the US alone, with annual costs to the healthcare system of $3.2 billion.
About the clinical trial site
Dr. Paul Evans earned his degree from Drew University, trained at The University of Connecticut School of Medicine, is Board certified in Family Practice, has been practicing with The Center for Excellence in Aging and Geriatric Health for four years.
The facility is located at 3901 Treyburn Dr., Suite 100, Williamsburg, VA 23185 and 12200 Warwick Blvd. Suite 490B, Newport News, VA 23601. For more information call 757-220-4751 or visit www.excellenceinaging.org.
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