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

NCT ID: NCT00269399

Last Updated: 2019-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 237 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2008-12-31

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.

Conditions

Clostridium Infections; Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Rifaximin Treatment Arm

rifaximin 400mg taken 3 times a day

Group Type: EXPERIMENTAL

Rifaximin (Xifaxan)

Intervention Type: DRUG

Vancomycin Comparator Arm

vancomycin 125mg taken 4 times a day

Group Type: ACTIVE_COMPARATOR

Vancomycin

Intervention Type: DRUG

Interventions

Rifaximin (Xifaxan)

Intervention Type: DRUG

Vancomycin

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

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

Shah Associates

Prince Frederick, Maryland, United States

Henry Ford Hospital

Detroit, Michigan, United States

Arnold Markowitz, MD, PC

Keego Harbor, Michigan, United States

Newland Medical Association

Southfield, Michigan, United States

St. Mary's/Duluth Clinic Health System

Duluth, Minnesota, United States

Minneapolis VAMC

Minneapolis, Minnesota, United States

Infectious Disease - Minneapolis Ltd.

Minneapolis, Minnesota, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Digestive Health Specialists, PA

Tupelo, Mississippi, United States

Deaconess Billings Clinic Research

Billings, Montana, United States

Infectious Diseases Associates, PC

Omaha, Nebraska, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Drs. Scherl, Chessler, Zingler, Spinnel and Meininger

Fort Lee, New Jersey, United States

Marlboro Gastroenterology PC

Manalapan, New Jersey, United States

St. Michael's Medical Center

Newark, New Jersey, United States

Institute for Clinical Research (ICR) at Holy Name Hospital

Teaneck, New Jersey, United States

The Gastroenterology Group of South Jersey

Vineland, New Jersey, United States

Brookdale University Hospital and Medical Center

Brooklyn, New York, United States

AMS Clinical Research

Elmira, New York, United States

North Shore Hepatology

Manhasset, New York, United States

Weill Medical College

New York, New York, United States

University of Rochester School of Medicine

Rochester, New York, United States

New York Medical College/Westchester Medical Center

Valhalla, New York, United States

East Carolina Gastroenterology, PA

Jacksonville, North Carolina, United States

Southern Gastroenterology Associates

New Bern, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Regional Infectious Diseases - Infusion Center

Lima, Ohio, United States

Lima Memorial Health System

Lima, Ohio, United States

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

Drexel University College of Medicine

Philadelphia, Pennsylvania, United States

RPS Infectious Diseases

West Reading, Pennsylvania, United States

University Gastroenterology

Providence, Rhode Island, United States

Digestive Disease Associates of Dallas

Dallas, Texas, United States

Michael E. DeBakey VA Medical Center

Houston, Texas, United States

University of Texas Health Sciences Center

Houston, Texas, United States

Infectious Disease Associates of Central Virginia

Lynchburg, Virginia, United States

North Pacific Clinical Research

Redmond, Washington, United States

Associated Physicians, LLP

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

RFCL3001

Identifier Type: -

Identifier Source: org_study_id