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

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00269399
First received: December 22, 2005
Last updated: July 17, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Clostridium Infections
Diarrhea
Drug: Rifaximin (Xifaxan)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 300
Study Start Date: December 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269399

  Show 63 Study Locations
Sponsors and Collaborators
Salix Pharmaceuticals
  More Information

No publications provided

Responsible Party: Audrey L. Shaw, PhD, Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00269399     History of Changes
Other Study ID Numbers: RFCL3001
Study First Received: December 22, 2005
Last Updated: July 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:
Clostridium difficile-associated Diarrhea (CDAD)
CDAD
C diff

Additional relevant MeSH terms:
Diarrhea
Clostridium Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Gram-Positive Bacterial Infections
Bacterial Infections
Rifaximin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 18, 2014