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

Sponsor:	Salix Pharmaceuticals
Information provided by:	Salix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00269399

Purpose

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).

Condition	Intervention	Phase
Clostridium Infections Diarrhea	Drug: Rifaximin (Xifaxan)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Official Title:	A Double-Blind, Randomized, Controlled Trial of Rifaximin Compared to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea

Drug Information available for: Rifaximin Vancomycin Vancomycin hydrochloride

U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:

The primary endpoint is the proportion of subjects achieving clinical success, where clinical success is defined as resolution or improvement of baseline signs and symptoms i.e., abdominal pain, fever, diarrhea.

Secondary Outcome Measures:

The secondary endpoint will be the proportion of subjects who have a recurrence of CDAD, with recurrence defined as diarrhea and a positive Clostridium difficile stool toxin assay that occurs after initial clinical success.

Estimated Enrollment:	300
Study Start Date:	December 2005
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269399

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Locations

United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, California
Inland Empire Digestive & Liver Diseases
Redlands, California, United States, 92373
United States, Colorado
Gastroenterology of the Rockies
Longmont, Colorado, United States, 80501
United States, Connecticut
Connecticut Gastroenterology Institute
Bristol, Connecticut, United States, 06010-0977
United States, District of Columbia
The George Washington University Medical Center
Washington, District of Columbia, United States, 20037
United States, Florida
Webster Surgical Center LLC
Tallahassee, Florida, United States, 32308
Advanced Medical Research Center
Port Orange, Florida, United States, 32127
Halifax Medical Center
Daytona Beach, Florida, United States, 32114
United States, Georgia
Southeast Regional Research Group
Columbus, Georgia, United States, 31904
Digestive Healthcare of Georgia
Atlanta, Georgia, United States, 30309
United States, Idaho
Sky Blue, M.D.
Boise, Idaho, United States, 83712
United States, Illinois
Carle Clinic Association NCW5
Urbana, Illinois, United States, 61801
Springfield Clinic
Springfield, Illinois, United States, 62701
Memorial Medical Center
Springfield, Illinois, United States, 62702
Gastroenterology, Ltd.
Peoria, Illinois, United States, 61602
The University of Chicago
Chicago, Illinois, United States, 60637
Howard Brown Health Center
Chicago, Illinois, United States, 60613
United States, Iowa
Iowa Digestive Disease Center, PC
Des Moines, Iowa, United States, 50312-5300
United States, Kansas
Kansas Medical Clinic
Topeka, Kansas, United States, 66606
GI Specialists
Olathe, Kansas, United States, 66061
Gastrointestinal Associates
Overland Park, Kansas, United States, 66212
United States, Maryland
Center for Clinical Research at Washington County Hospital
Hagerstown, Maryland, United States, 21740
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
Shah Associates
Prince Frederick, Maryland, United States, 20678
University of Maryland
Baltimore, Maryland, United States, 21201
Baltimore VA Medical Center
Baltimore, Maryland, United States, 21201
United States, Michigan
Arnold Markowitz, MD, PC
Keego Harbor, Michigan, United States, 48320
Newland Medical Association
Southfield, Michigan, United States, 48075
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
St. Mary's/Duluth Clinic Health System
Duluth, Minnesota, United States, 55805
Infectious Disease - Minneapolis Ltd.
Minneapolis, Minnesota, United States, 55422
Minneapolis VAMC
Minneapolis, Minnesota, United States, 55417
United States, Mississippi
Digestive Health Specialists, PA
Tupelo, Mississippi, United States, 38801
United States, Montana
Deaconess Billings Clinic Research
Billings, Montana, United States, 59101
United States, Nebraska
Infectious Diseases Associates, PC
Omaha, Nebraska, United States, 68114
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebannon, New Hampshire, United States, 03756
United States, New Jersey
The Gastroenterology Group of South Jersey
Vineland, New Jersey, United States, 08360
Institute for Clinical Research (ICR) at Holy Name Hospital
Teaneck, New Jersey, United States, 07666
Drs. Scherl, Chessler, Zingler, Spinnel and Meininger
Fort Lee, New Jersey, United States, 07024
Marlboro Gastroenterology PC
Manalapan, New Jersey, United States, 07726
St. Michael's Medical Center
Newark, New Jersey, United States, 07102
United States, New York
Brookdale University Hospital and Medical Center
Brooklyn, New York, United States, 11212
University of Rochester School of Medicine
Rochester, New York, United States, 14642
New York Medical College/Westchester Medical Center
Valhalla, New York, United States, 10595
AMS Clinical Research
Elmira, New York, United States, 14905
North Shore Hepatology
Manhasset, New York, United States, 11030
Weill Medical College
New York, New York, United States, 10021
United States, North Carolina
East Carolina Gastroenterology, PA
Jacksonville, North Carolina, United States, 28546
Southern Gastroenterology Associates
New Bern, North Carolina, United States, 28562
United States, Ohio
Regional Infectious Diseases - Infusion Center
Lima, Ohio, United States, 45801
Lima Memorial Health System
Lima, Ohio, United States, 45804
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0595
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
RPS Infectious Diseases
West Reading, Pennsylvania, United States, 19611
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
University Gastroenterology
Providence, Rhode Island, United States, 02905
United States, Texas
University of Texas Health Sciences Center
Houston, Texas, United States, 77030
Digestive Disease Associates of Dallas
Dallas, Texas, United States, 75231
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
United States, Virginia
Infectious Disease Associates of Central Virginia
Lynchburg, Virginia, United States, 24501
United States, Washington
North Pacific Clinical Research
Redmond, Washington, United States, 98052
United States, Wisconsin
Associated Physicians, LLP
Madison, Wisconsin, United States, 53705

Sponsors and Collaborators

Salix Pharmaceuticals

More Information

No publications provided

Responsible Party:	Salix Pharmaceuticals ( Audrey L. Shaw, PhD )
Study ID Numbers:	RFCL3001
Study First Received:	December 22, 2005
Last Updated:	April 8, 2009
ClinicalTrials.gov Identifier:	NCT00269399 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:

Clostridium difficile-associated Diarrhea (CDAD)
CDAD
C diff

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Diarrhea
Signs and Symptoms, Digestive
Gastrointestinal Agents
Infection
Pharmacologic Actions

Signs and Symptoms
Anti-Bacterial Agents
Gram-Positive Bacterial Infections
Therapeutic Uses
Vancomycin
Rifaximin
Clostridium Infections

ClinicalTrials.gov processed this record on November 25, 2009