Clinical trial NCT00269399: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Clostridium Infections
Diarrhea
Keywords: Clostridium difficile-associated Diarrhea (CDAD)
CDAD
C diff
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2005-12-23
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 14 days
Secondary outcomes:
measure: Proportion of Participants Recurrence-free of Clostridium Difficile-associated Diarrhea (CDAD), After Achieving Clinical Success
timeFrame: 42 days
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Scottsdale
state: Arizona
city: Redlands
country: United States
facility: Inland Empire Digestive & Liver Diseases
state: California
city: Longmont
country: United States
facility: Gastroenterology of the Rockies
state: Colorado
city: Bristol
country: United States
facility: Connecticut Gastroenterology Institute
state: Connecticut
city: Washington
country: United States
facility: The George Washington University Medical Center
state: District of Columbia
city: Daytona Beach
country: United States
facility: Halifax Medical Center
state: Florida
city: Port Orange
country: United States
facility: Advanced Medical Research Center
state: Florida
city: Tallahassee
country: United States
facility: Webster Surgical Center LLC
state: Florida
city: Atlanta
country: United States
facility: Digestive Healthcare of Georgia
state: Georgia
city: Columbus
country: United States
facility: Southeast Regional Research Group
state: Georgia
city: Boise
country: United States
facility: Sky Blue, M.D.
state: Idaho
city: Chicago
country: United States
facility: Howard Brown Health Center
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Peoria
country: United States
facility: Gastroenterology, Ltd.
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Springfield
country: United States
facility: Memorial Medical Center
state: Illinois
city: Urbana
country: United States
facility: Carle Clinic Association NCW5
state: Illinois
city: Des Moines
country: United States
facility: Iowa Digestive Disease Center, PC
state: Iowa
city: Olathe
country: United States
facility: GI Specialists
state: Kansas
city: Overland Park
country: United States
facility: Gastrointestinal Associates
state: Kansas
city: Topeka
country: United States
facility: Kansas Medical Clinic
state: Kansas
city: Baltimore
country: United States
facility: Baltimore VA Medical Center
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Hagerstown
country: United States
facility: Center for Clinical Research at Washington County Hospital
state: Maryland
city: Prince Frederick
country: United States
facility: Shah Associates
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Keego Harbor
country: United States
facility: Arnold Markowitz, MD, PC
state: Michigan
city: Southfield
country: United States
facility: Newland Medical Association
state: Michigan
city: Duluth
country: United States
facility: St. Mary's/Duluth Clinic Health System
state: Minnesota
city: Minneapolis
country: United States
facility: Minneapolis VAMC
state: Minnesota
city: Minneapolis
country: United States
facility: Infectious Disease - Minneapolis Ltd.
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Tupelo
country: United States
facility: Digestive Health Specialists, PA
state: Mississippi
city: Billings
country: United States
facility: Deaconess Billings Clinic Research
state: Montana
city: Omaha
country: United States
facility: Infectious Diseases Associates, PC
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Fort Lee
country: United States
facility: Drs. Scherl, Chessler, Zingler, Spinnel and Meininger
state: New Jersey
city: Manalapan
country: United States
facility: Marlboro Gastroenterology PC
state: New Jersey
city: Newark
country: United States
facility: St. Michael's Medical Center
state: New Jersey
city: Teaneck
country: United States
facility: Institute for Clinical Research (ICR) at Holy Name Hospital
state: New Jersey
city: Vineland
country: United States
facility: The Gastroenterology Group of South Jersey
state: New Jersey
city: Brooklyn
country: United States
facility: Brookdale University Hospital and Medical Center
state: New York
city: Elmira
country: United States
facility: AMS Clinical Research
state: New York
city: Manhasset
country: United States
facility: North Shore Hepatology
state: New York
city: New York
country: United States
facility: Weill Medical College
state: New York
city: Rochester
country: United States
facility: University of Rochester School of Medicine
state: New York
city: Valhalla
country: United States
facility: New York Medical College/Westchester Medical Center
state: New York
city: Jacksonville
country: United States
facility: East Carolina Gastroenterology, PA
state: North Carolina
city: New Bern
country: United States
facility: Southern Gastroenterology Associates
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Lima
country: United States
facility: Regional Infectious Diseases - Infusion Center
state: Ohio
city: Lima
country: United States
facility: Lima Memorial Health System
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: West Reading
country: United States
facility: RPS Infectious Diseases
state: Pennsylvania
city: Providence
country: United States
facility: University Gastroenterology
state: Rhode Island
city: Dallas
country: United States
facility: Digestive Disease Associates of Dallas
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
city: Houston
country: United States
facility: University of Texas Health Sciences Center
state: Texas
city: Lynchburg
country: United States
facility: Infectious Disease Associates of Central Virginia
state: Virginia
city: Redmond
country: United States
facility: North Pacific Clinical Research
state: Washington
city: Madison
country: United States
facility: Associated Physicians, LLP
state: Wisconsin
Study officials:
References: