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Sanofi Pasteur, the vaccines division of Sanofi, announced the initiation of its Phase III clinical program called Cdiffense to evaluate the safety, immunogenicity and efficacy of an experimental vaccine for the prevention of symptomatic primary infection with Clostridium difficile (ICD). Clostridium difficile (C. diff) is a potentially lethal, urine infection spore-forming bacterium urine infection that causes intestinal urine infection diseases. The risk involved in this infection urine infection increases with age, antibiotic treatment and length of stay in hospitals or nursing homes, where the appearance of several cases can lead to outbreaks. The study vaccine is designed to help protect people at risk of contracting C. diff, which is becoming the leading cause of life-threatening associated with hospital settings (HAI) infections worldwide. The toxins of C. difficile cause gastrointestinal diseases that can cause death to between 8% and 15% of those affected. Between 20% and 30% of patients experience recurrence of ICD, which implies frequent hospitalizations and longer hospital stays. The combined data from the United States (US) and European Union (EU) show that health systems spend more than 7 billion dollars a year in intensive care ICD. In Latin America, although data availability is not as wide as in the US and Europe, there is information reported by some countries to realize urine infection the impact of C. difficile infection. The experimental vaccine C. diff is designed to elicit an immune urine infection response directed to the toxins produced by the bacteria urine infection C. diff, which can cause inflammation of the bowel and cause diarrhea. The vaccine urine infection can help prevent future infection. "With the emergence of more resistant strains C. difficile infections by this organism are more frequent, more severe and difficult to treat, which raises concerns about the methods of control and prevention of transmission," said Dr. Fernando Noriega Vice President of Research and Development at Sanofi Pasteur for Latin America. The Phase III clinical program Cdiffense began recruiting volunteers in Mexico in 8 clinical sites in different parts of the country.
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