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Pivotal Phase 3 Studies Planned for Treatment of <i>Clostridium Difficile</i>-Associated Diarrhea
The studies are designed to compare the end-of-therapy response rates with CB-315 and oral vancomycin and to evaluate the safety of CB-315 in patients with CDAD. In addition, investigators will look at sustained clinical response after treatment.
CDAD is a disease caused by an overgrowth of, and subsequent toxin production by, C. difficile, a resident anaerobic spore-forming Gram-positive bacterium of the lower gastrointestinal (GI) tract. The overgrowth of C. difficile in the GI tract is caused by the use of antibiotics for the treatment of common community and hospital-acquired infections. Although antibiotics treat the underlying infection, many of these drugs disrupt the natural gut flora and allow C. difficile to proliferate. C. difficile produces toxins that can lead to severe diarrhea, sepsis, and even death.
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