กรุงเทพฯ--11 พ.ย.--Sanofi Thailand
Cdiffense trial to evaluate vaccine against a leading cause of life-threatening, healthcare-associated infections worldwide -
Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today the initiation of its Phase III clinical program in Thailand called Cdiffense to evaluate the safety, immunogenicity and efficacy of an investigational vaccine for the prevention of symptomatic Clostridium difficile infection (CDI). Clostridium difficile (C. diff) is a potentially life-threatening, spore-forming bacterium that causes intestinal disease. The risk of CDI increases with age, antibiotic treatment and time spent in hospitals or nursing homes, where multiple cases can lead to outbreaks. The investigational vaccine is designed to help protect at-risk individuals from CDI, which is emerging as a leading cause of life-threatening, healthcare-associated infections (HAIs) worldwide.[i]
Since 20 to 30 percent of patients experience recurrences of CDI, re-hospitalizations and longer hospital stays remain common.[ii]Although relatively few studies on C. difficile have been performed in Asia, what work has been done demonstrates that CDI is a significant cause of nosocomial disease in Asian countries.3 Sanofi Pasteur's investigational C. diff vaccine is designed to produce an immune response that targets the toxins generated by C. diff bacteria, which can cause inflammation of the gut and lead to diarrhea. The phase III clinical trial is designed to determine if the investigational vaccine will help prevent a future infection from occurring.
"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 Danaya Chansinghakul, Regional Director Clinical Development, at Sanofi Pasteur Thailand. "Vaccination could be an efficacious, cost-effective and important public-health measure to protect individuals from C. diff."
The Cdiffense Phase III clinical program has just started recruiting volunteers in Thailand for a randomized, observer-blind, placebo-controlled, multi-center, multi-national trial that will include up to 15,000 adults at 200 sites across 20+ countries. Volunteers for the study should be age 50 or older and are planning an upcoming hospitalization or have been in the hospital and received systemic antibiotics in the past year. For more information on the Cdiffense trial, please visit www.Cdiffense.org.