A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
A Double-Blind, Randomized, Controlled Trial of Rifaximin Compared to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
1 other identifier
interventional
237
1 country
63
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2005
Typical duration for phase_3
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 22, 2005
CompletedFirst Posted
Study publicly available on registry
December 23, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
October 1, 2019
CompletedOctober 14, 2019
September 1, 2019
3 years
December 22, 2005
September 6, 2019
September 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Participants Achieving Clinical Success, Where Clinical Success is Defined as Resolution or Improvement of Baseline Signs and Symptoms i.e., Abdominal Pain, Fever, Diarrhea.
Resolution or improvement of baseline signs and symptoms was assessed as * Absence of severe abdominal pain for 2 consecutive days at the test of cure (TOC) Visit (Day 14 +/-1); * Absence of fever (\< 38°C/100.4°F) for 2 consecutive days at the TOC Visit; and * 3 unformed (loose or watery) stools per day for at least 48 hours that was sustained through the TOC Visit.
14 days
Secondary Outcomes (1)
Proportion of Participants Recurrence-free of Clostridium Difficile-associated Diarrhea (CDAD), After Achieving Clinical Success
42 days
Study Arms (2)
Rifaximin Treatment Arm
EXPERIMENTALrifaximin 400mg taken 3 times a day
Vancomycin Comparator Arm
ACTIVE COMPARATORvancomycin 125mg taken 4 times a day
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259, United States
Inland Empire Digestive & Liver Diseases
Redlands, California, 92373, United States
Gastroenterology of the Rockies
Longmont, Colorado, 80501, United States
Connecticut Gastroenterology Institute
Bristol, Connecticut, 06010-0977, United States
The George Washington University Medical Center
Washington D.C., District of Columbia, 20037, United States
Halifax Medical Center
Daytona Beach, Florida, 32114, United States
Advanced Medical Research Center
Port Orange, Florida, 32127, United States
Webster Surgical Center LLC
Tallahassee, Florida, 32308, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309, United States
Southeast Regional Research Group
Columbus, Georgia, 31904, United States
Sky Blue, M.D.
Boise, Idaho, 83712, United States
Howard Brown Health Center
Chicago, Illinois, 60613, United States
The University of Chicago
Chicago, Illinois, 60637, United States
Gastroenterology, Ltd.
Peoria, Illinois, 61602, United States
Springfield Clinic
Springfield, Illinois, 62701, United States
Memorial Medical Center
Springfield, Illinois, 62702, United States
Carle Clinic Association NCW5
Urbana, Illinois, 61801, United States
Iowa Digestive Disease Center, PC
Des Moines, Iowa, 50312-5300, United States
GI Specialists
Olathe, Kansas, 66061, United States
Gastrointestinal Associates
Overland Park, Kansas, 66212, United States
Kansas Medical Clinic
Topeka, Kansas, 66606, United States
Baltimore VA Medical Center
Baltimore, Maryland, 21201, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Center for Clinical Research at Washington County Hospital
Hagerstown, Maryland, 21740, United States
Shah Associates
Prince Frederick, Maryland, 20678, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Arnold Markowitz, MD, PC
Keego Harbor, Michigan, 48320, United States
Newland Medical Association
Southfield, Michigan, 48075, United States
St. Mary's/Duluth Clinic Health System
Duluth, Minnesota, 55805, United States
Minneapolis VAMC
Minneapolis, Minnesota, 55417, United States
Infectious Disease - Minneapolis Ltd.
Minneapolis, Minnesota, 55422, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Digestive Health Specialists, PA
Tupelo, Mississippi, 38801, United States
Deaconess Billings Clinic Research
Billings, Montana, 59101, United States
Infectious Diseases Associates, PC
Omaha, Nebraska, 68114, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Drs. Scherl, Chessler, Zingler, Spinnel and Meininger
Fort Lee, New Jersey, 07024, United States
Marlboro Gastroenterology PC
Manalapan, New Jersey, 07726, United States
St. Michael's Medical Center
Newark, New Jersey, 07102, United States
Institute for Clinical Research (ICR) at Holy Name Hospital
Teaneck, New Jersey, 07666, United States
The Gastroenterology Group of South Jersey
Vineland, New Jersey, 08360, United States
Brookdale University Hospital and Medical Center
Brooklyn, New York, 11212, United States
AMS Clinical Research
Elmira, New York, 14905, United States
North Shore Hepatology
Manhasset, New York, 11030, United States
Weill Medical College
New York, New York, 10021, United States
University of Rochester School of Medicine
Rochester, New York, 14642, United States
New York Medical College/Westchester Medical Center
Valhalla, New York, 10595, United States
East Carolina Gastroenterology, PA
Jacksonville, North Carolina, 28546, United States
Southern Gastroenterology Associates
New Bern, North Carolina, 28562, United States
University of Cincinnati
Cincinnati, Ohio, 45267-0595, United States
Regional Infectious Diseases - Infusion Center
Lima, Ohio, 45801, United States
Lima Memorial Health System
Lima, Ohio, 45804, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19107, United States
RPS Infectious Diseases
West Reading, Pennsylvania, 19611, United States
University Gastroenterology
Providence, Rhode Island, 02905, United States
Digestive Disease Associates of Dallas
Dallas, Texas, 75231, United States
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030, United States
University of Texas Health Sciences Center
Houston, Texas, 77030, United States
Infectious Disease Associates of Central Virginia
Lynchburg, Virginia, 24501, United States
North Pacific Clinical Research
Redmond, Washington, 98052, United States
Associated Physicians, LLP
Madison, Wisconsin, 53705, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Operations
- Organization
- Bausch Health Americas, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2005
First Posted
December 23, 2005
Study Start
December 1, 2005
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
October 14, 2019
Results First Posted
October 1, 2019
Record last verified: 2019-09