A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)

Completed · Phase 3

Conditions studied: Clostridium Infections, Diarrhea

In brief

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).

Key facts

Study ID

NCT00269399

Run by

Bausch Health Americas, Inc.

People needed

237

Starts

2005-12-01

Expected to finish

2008-12-01

Last updated by the study team

2019-10-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Inland Empire Digestive & Liver Diseases — Redlands, California, United States
• Gastroenterology of the Rockies — Longmont, Colorado, United States
• Connecticut Gastroenterology Institute — Bristol, Connecticut, United States
• The George Washington University Medical Center — Washington D.C., District of Columbia, United States
• Halifax Medical Center — Daytona Beach, Florida, United States
• Advanced Medical Research Center — Port Orange, Florida, United States
• Webster Surgical Center LLC — Tallahassee, Florida, United States
• Digestive Healthcare of Georgia — Atlanta, Georgia, United States
• Southeast Regional Research Group — Columbus, Georgia, United States
• Sky Blue, M.D. — Boise, Idaho, United States
• Howard Brown Health Center — Chicago, Illinois, United States
• The University of Chicago — Chicago, Illinois, United States
• Gastroenterology, Ltd. — Peoria, Illinois, United States
• Springfield Clinic — Springfield, Illinois, United States
• Memorial Medical Center — Springfield, Illinois, United States
• Carle Clinic Association NCW5 — Urbana, Illinois, United States
• Iowa Digestive Disease Center, PC — Des Moines, Iowa, United States
• GI Specialists — Olathe, Kansas, United States
• Gastrointestinal Associates — Overland Park, Kansas, United States
• Kansas Medical Clinic — Topeka, Kansas, United States
• Baltimore VA Medical Center — Baltimore, Maryland, United States
• University of Maryland — Baltimore, Maryland, United States
• Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
• Center for Clinical Research at Washington County Hospital — Hagerstown, Maryland, United States
• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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