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

Diarrhea Clinical Trial

Official title:

A Double-Blind, Randomized, Controlled Trial of Rifaximin Compared to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00269399
• Other study ID #: RFCL3001
• Status: Completed
• Phase: Phase 3
• Start date: December 2005
• Est. completion date: December 2008

Study information

• Verified date: September 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Clostridium Infections
• Diarrhea

Intervention

Drug:
• Rifaximin (Xifaxan)

• Vancomycin

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	14 days
Secondary	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.	42 days