A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
- Conditions
- Clostridium InfectionsDiarrhea
- Interventions
- Registration Number
- NCT00269399
- Lead Sponsor
- Bausch Health Americas, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 237
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vancomycin Comparator Arm Vancomycin vancomycin 125mg taken 4 times a day Rifaximin Treatment Arm Rifaximin (Xifaxan) rifaximin 400mg taken 3 times a day
- Primary Outcome Measures
Name Time Method 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. 14 days 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
Name Time Method Proportion of Participants Recurrence-free of Clostridium Difficile-associated Diarrhea (CDAD), After Achieving Clinical Success 42 days Recurrence of CDAD was defined as diarrhea and a positive Clostridium difficile stool toxin assay that occurs after initial clinical success.
Trial Locations
- Locations (63)
Newland Medical Association
🇺🇸Southfield, Michigan, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Digestive Health Specialists, PA
🇺🇸Tupelo, Mississippi, United States
East Carolina Gastroenterology, PA
🇺🇸Jacksonville, North Carolina, United States
Baltimore VA Medical Center
🇺🇸Baltimore, Maryland, United States
Center for Clinical Research at Washington County Hospital
🇺🇸Hagerstown, Maryland, United States
Shah Associates
🇺🇸Prince Frederick, Maryland, United States
The University of Chicago
🇺🇸Chicago, Illinois, United States
Michael E. DeBakey VA Medical Center
🇺🇸Houston, Texas, United States
Minneapolis VAMC
🇺🇸Minneapolis, Minnesota, United States
Infectious Disease - Minneapolis Ltd.
🇺🇸Minneapolis, Minnesota, United States
Kansas Medical Clinic
🇺🇸Topeka, Kansas, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Inland Empire Digestive & Liver Diseases
🇺🇸Redlands, California, United States
Gastroenterology of the Rockies
🇺🇸Longmont, Colorado, United States
Halifax Medical Center
🇺🇸Daytona Beach, Florida, United States
The George Washington University Medical Center
🇺🇸Washington, District of Columbia, United States
Webster Surgical Center LLC
🇺🇸Tallahassee, Florida, United States
Digestive Healthcare of Georgia
🇺🇸Atlanta, Georgia, United States
Sky Blue, M.D.
🇺🇸Boise, Idaho, United States
Southeast Regional Research Group
🇺🇸Columbus, Georgia, United States
Gastroenterology, Ltd.
🇺🇸Peoria, Illinois, United States
Howard Brown Health Center
🇺🇸Chicago, Illinois, United States
Carle Clinic Association NCW5
🇺🇸Urbana, Illinois, United States
Springfield Clinic
🇺🇸Springfield, Illinois, United States
Memorial Medical Center
🇺🇸Springfield, 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
Chevy Chase Clinical Research
🇺🇸Chevy Chase, Maryland, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Arnold Markowitz, MD, PC
🇺🇸Keego Harbor, Michigan, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
Deaconess Billings Clinic Research
🇺🇸Billings, Montana, United States
St. Michael's Medical Center
🇺🇸Newark, New Jersey, United States
Infectious Diseases Associates, PC
🇺🇸Omaha, Nebraska, United States
Drs. Scherl, Chessler, Zingler, Spinnel and Meininger
🇺🇸Fort Lee, New Jersey, United States
Marlboro Gastroenterology PC
🇺🇸Manalapan, 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
AMS Clinical Research
🇺🇸Elmira, New York, United States
Brookdale University Hospital and Medical Center
🇺🇸Brooklyn, New York, United States
North Shore Hepatology
🇺🇸Manhasset, New York, United States
New York Medical College/Westchester Medical Center
🇺🇸Valhalla, New York, United States
University of Rochester School of Medicine
🇺🇸Rochester, New York, United States
Weill Medical College
🇺🇸New York, New York, United States
Southern Gastroenterology Associates
🇺🇸New Bern, North Carolina, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Lima Memorial Health System
🇺🇸Lima, Ohio, United States
Regional Infectious Diseases - Infusion Center
🇺🇸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
University of Texas Health Sciences Center
🇺🇸Houston, Texas, United States
Associated Physicians, LLP
🇺🇸Madison, Wisconsin, United States
Infectious Disease Associates of Central Virginia
🇺🇸Lynchburg, Virginia, United States
North Pacific Clinical Research
🇺🇸Redmond, Washington, United States
St. Mary's/Duluth Clinic Health System
🇺🇸Duluth, Minnesota, United States
Connecticut Gastroenterology Institute
🇺🇸Bristol, Connecticut, United States
Advanced Medical Research Center
🇺🇸Port Orange, Florida, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States