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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00269399
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : July 19, 2011
Information provided by:
Valeant Pharmaceuticals International, 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).

Condition or disease Intervention/treatment Phase
Clostridium Infections Diarrhea Drug: Rifaximin (Xifaxan) Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Controlled Trial of Rifaximin Compared to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
Study Start Date : December 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00269399

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Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.

Responsible Party: Audrey L. Shaw, PhD, Salix Pharmaceuticals Identifier: NCT00269399     History of Changes
Other Study ID Numbers: RFCL3001
First Posted: December 23, 2005    Key Record Dates
Last Update Posted: July 19, 2011
Last Verified: July 2011

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Clostridium difficile-associated Diarrhea (CDAD)
C diff

Additional relevant MeSH terms:
Clostridium Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action