Back to resultsA Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
Primary Purpose
Clostridium Infections, Diarrhea
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rifaximin (Xifaxan)
Vancomycin
Sponsored by
About this trial
This is an interventional treatment trial for Clostridium Infections focused on measuring Clostridium difficile-associated Diarrhea (CDAD), CDAD, C diff
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- Mayo Clinic Scottsdale
- Inland Empire Digestive & Liver Diseases
- Gastroenterology of the Rockies
- Connecticut Gastroenterology Institute
- The George Washington University Medical Center
- Halifax Medical Center
- Advanced Medical Research Center
- Webster Surgical Center LLC
- Digestive Healthcare of Georgia
- Southeast Regional Research Group
- Sky Blue, M.D.
- Howard Brown Health Center
- The University of Chicago
- Gastroenterology, Ltd.
- Springfield Clinic
- Memorial Medical Center
- Carle Clinic Association NCW5
- Iowa Digestive Disease Center, PC
- GI Specialists
- Gastrointestinal Associates
- Kansas Medical Clinic
- Baltimore VA Medical Center
- University of Maryland
- Chevy Chase Clinical Research
- Center for Clinical Research at Washington County Hospital
- Shah Associates
- Henry Ford Hospital
- Arnold Markowitz, MD, PC
- Newland Medical Association
- St. Mary's/Duluth Clinic Health System
- Minneapolis VAMC
- Infectious Disease - Minneapolis Ltd.
- Mayo Clinic Rochester
- Digestive Health Specialists, PA
- Deaconess Billings Clinic Research
- Infectious Diseases Associates, PC
- Dartmouth Hitchcock Medical Center
- Drs. Scherl, Chessler, Zingler, Spinnel and Meininger
- Marlboro Gastroenterology PC
- St. Michael's Medical Center
- Institute for Clinical Research (ICR) at Holy Name Hospital
- The Gastroenterology Group of South Jersey
- Brookdale University Hospital and Medical Center
- AMS Clinical Research
- North Shore Hepatology
- Weill Medical College
- University of Rochester School of Medicine
- New York Medical College/Westchester Medical Center
- East Carolina Gastroenterology, PA
- Southern Gastroenterology Associates
- University of Cincinnati
- Regional Infectious Diseases - Infusion Center
- Lima Memorial Health System
- Lehigh Valley Hospital
- Drexel University College of Medicine
- RPS Infectious Diseases
- University Gastroenterology
- Digestive Disease Associates of Dallas
- Michael E. DeBakey VA Medical Center
- University of Texas Health Sciences Center
- Infectious Disease Associates of Central Virginia
- North Pacific Clinical Research
- Associated Physicians, LLP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rifaximin Treatment Arm
Vancomycin Comparator Arm
Arm Description
rifaximin 400mg taken 3 times a day
vancomycin 125mg taken 4 times a day
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Proportion of Participants Recurrence-free of Clostridium Difficile-associated Diarrhea (CDAD), After Achieving Clinical Success
Recurrence of CDAD was defined as diarrhea and a positive Clostridium difficile stool toxin assay that occurs after initial clinical success.
Full Information
NCT ID
NCT00269399
First Posted
December 22, 2005
Last Updated
September 30, 2019
Sponsor
Bausch Health Americas, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00269399
Brief Title
A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
Official Title
A Double-Blind, Randomized, Controlled Trial of Rifaximin Compared to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.
4. Oversight
5. Study Description
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 lumen of the colon. Once established, it produces 2 potent toxins, A and B. The principal reservoir for Clostridium difficile is the hospital environment, with the risk of acquiring Clostridium difficile increasing in direct proportion to the length of hospital stay.
Patients with CDAD typically present with profuse watery or mucoid diarrhea and cramping abdominal pain. Additional symptoms include fever, nausea, anorexia, malaise, and bloody stool. More severe cases may be complicated by dehydration, electrolyte disturbances, ileus, and peritonitis. Systemic manifestations may include prerenal azotemia, sepsis syndrome, and toxic colitis. White blood cell counts (WBCs) also may be markedly elevated with a shift to immature forms. Extreme presentation of fulminant colitis may require a colectomy and even result in death. Symptoms of CDAD may begin a few days after initiation of antibiotic therapy or up to 8 weeks after its discontinuation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Infections, Diarrhea
Keywords
Clostridium difficile-associated Diarrhea (CDAD), CDAD, C diff
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
237 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rifaximin Treatment Arm
Arm Type
Experimental
Arm Description
rifaximin 400mg taken 3 times a day
Arm Title
Vancomycin Comparator Arm
Arm Type
Active Comparator
Arm Description
vancomycin 125mg taken 4 times a day
Intervention Type
Drug
Intervention Name(s)
Rifaximin (Xifaxan)
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Proportion of Participants Recurrence-free of Clostridium Difficile-associated Diarrhea (CDAD), After Achieving Clinical Success
Description
Recurrence of CDAD was defined as diarrhea and a positive Clostridium difficile stool toxin assay that occurs after initial clinical success.
Time Frame
42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Facility Information:
Facility Name
Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Inland Empire Digestive & Liver Diseases
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
Facility Name
Gastroenterology of the Rockies
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Connecticut Gastroenterology Institute
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010-0977
Country
United States
Facility Name
The George Washington University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Halifax Medical Center
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Advanced Medical Research Center
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Webster Surgical Center LLC
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Digestive Healthcare of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Southeast Regional Research Group
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Sky Blue, M.D.
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Howard Brown Health Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60613
Country
United States
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Gastroenterology, Ltd.
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Springfield Clinic
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Carle Clinic Association NCW5
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Iowa Digestive Disease Center, PC
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50312-5300
Country
United States
Facility Name
GI Specialists
City
Olathe
State/Province
Kansas
ZIP/Postal Code
66061
Country
United States
Facility Name
Gastrointestinal Associates
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Kansas Medical Clinic
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Baltimore VA Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Center for Clinical Research at Washington County Hospital
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Shah Associates
City
Prince Frederick
State/Province
Maryland
ZIP/Postal Code
20678
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Arnold Markowitz, MD, PC
City
Keego Harbor
State/Province
Michigan
ZIP/Postal Code
48320
Country
United States
Facility Name
Newland Medical Association
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
St. Mary's/Duluth Clinic Health System
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Minneapolis VAMC
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Infectious Disease - Minneapolis Ltd.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Digestive Health Specialists, PA
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Deaconess Billings Clinic Research
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Infectious Diseases Associates, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Drs. Scherl, Chessler, Zingler, Spinnel and Meininger
City
Fort Lee
State/Province
New Jersey
ZIP/Postal Code
07024
Country
United States
Facility Name
Marlboro Gastroenterology PC
City
Manalapan
State/Province
New Jersey
ZIP/Postal Code
07726
Country
United States
Facility Name
St. Michael's Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
Institute for Clinical Research (ICR) at Holy Name Hospital
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
The Gastroenterology Group of South Jersey
City
Vineland
State/Province
New Jersey
ZIP/Postal Code
08360
Country
United States
Facility Name
Brookdale University Hospital and Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11212
Country
United States
Facility Name
AMS Clinical Research
City
Elmira
State/Province
New York
ZIP/Postal Code
14905
Country
United States
Facility Name
North Shore Hepatology
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Weill Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Rochester School of Medicine
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
New York Medical College/Westchester Medical Center
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
East Carolina Gastroenterology, PA
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28546
Country
United States
Facility Name
Southern Gastroenterology Associates
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0595
Country
United States
Facility Name
Regional Infectious Diseases - Infusion Center
City
Lima
State/Province
Ohio
ZIP/Postal Code
45801
Country
United States
Facility Name
Lima Memorial Health System
City
Lima
State/Province
Ohio
ZIP/Postal Code
45804
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
RPS Infectious Diseases
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
University Gastroenterology
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Digestive Disease Associates of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Michael E. DeBakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Sciences Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Infectious Disease Associates of Central Virginia
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
North Pacific Clinical Research
City
Redmond
State/Province
Washington
ZIP/Postal Code
98052
Country
United States
Facility Name
Associated Physicians, LLP
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
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