Trial Information

Summary: A Double-Blind, Randomized, Controlled Trial of Rifaximin Compared to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)

The purpose of this study is to demonstrate the efficacy and safety of a 10-day course of rifaximin as compared to vancomycin for treatment of Clostridium difficile-associated diarrhea (CDAD).

Inclusion Criteria: Men and women 18 years and older with acute diarrhea and at least one other sign of enteric infection present, such as fever, nausea/loss of appetite, vomiting, severe abdominal pain or discomfort.

Exclusion Criteria: Patients who have had a previous episode of clinically diagnosed Clostridium difficile within the past six months. Patients who have a chronic disease associated with diarrhea (e.g., inflammatory bowel disease, diarrhea predominant IBS). Patients with protocol deviations deemed to have a significant impact on efficacy variables will be excluded.

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Trial listings updated: June 1, 2008 at 5:46:16 AM