Status:
COMPLETED
A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Clostridium Infections
Diarrhea
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the treatment and safety of a 10-day course of rifaximin (Xifaxan) as compared to vancomycin for treatment of Clostridium difficile-associated diarrhea (CDAD).
Detailed Description
Clostridium difficile is a bacterium that proliferates when normal colonic flora have been altered, most commonly due to antibiotic use. Clostridium difficile is non-invasive and localized to the lume...
Eligibility Criteria
Inclusion
- Subject is 18 years of age or older, has acute diarrhea and at least 1 other sign of enteric infection present, such as fever, nausea/loss of appetite, vomiting, severe abdominal pain or discomfort.
- Subject has a positive Clostridium difficile stool toxin assay at screening
Exclusion
- Subject has had a previous episode of clinically diagnosed Clostridium difficile within the past 6 months.
- Subject has chronic diseases associated with diarrhea (e.g., inflammatory bowel disease or diarrhea predominant irritable bowel syndrome \[DIBS\])
- Subject has had any therapy with any agent administered for the treatment of Clostridium difficile prior to randomization.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT00269399
Start Date
December 1 2005
End Date
December 1 2008
Last Update
October 14 2019
Active Locations (63)
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1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
2
Inland Empire Digestive & Liver Diseases
Redlands, California, United States, 92373
3
Gastroenterology of the Rockies
Longmont, Colorado, United States, 80501
4
Connecticut Gastroenterology Institute
Bristol, Connecticut, United States, 06010-0977