Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00182429
First received: September 13, 2005
Last updated: February 15, 2006
Last verified: April 2005
  Purpose

What is the difference between the use of one drug (Oral Metronidazole) versus the use of this same drug combined with another drug (Rifampin) in treatment of bacteria and infection-associated diarrhea in patients? This infection is an important cause of morbidity and mortality in both the community and hospitals, and the leading cause of hospital and chronic facility-acquired diarrhea. Research is important for the treatment of this infection. Patient care with use of two medication treatment regimens will be studied.


Condition Intervention Phase
Clostridium Enterocolitis
Antibiotic-Associated Diarrhea
Pseudomembranous Colitis
Pseudomembranous Enterocolitis
Pseudomembranous Enteritis
Drug: Metronidazole and Rifampin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Prospective, Randomized Study of Oral Metronidazole Vs. Oral Metronidazole and Rifampin for Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Resolution of symptoms in each treatment arm (in days) up to 40 days (measured using daily stool and symptom diary).

Secondary Outcome Measures:
  • Clinical relapse rate in each group (time to relapse in days) up to 40 days after initial diagnosis (measured by repeating C. difficile toxin assay and analyzing daily stool and symptom diary).
  • Adverse reactions related to treatment within 40 days (measured using daily symptom diary and interviewing patient).
  • Occurrance of metronidazole resistance in the organism (C. difficile) in relapse cases.

Estimated Enrollment: 100
Study Start Date: February 2004
Estimated Study Completion Date: April 2005
Detailed Description:

Clostridium difficile infection contributes to both community and hospital acquired morbidity and mortality. Metronidazole alone is usually considered the drug of choice, however, frequent relapses occur at a rate of 10-40%. The purpose of this study is to address the use of a combined drug regimen treatment (Metronidazole and Rifampin) for the treatment of CDAD. These drugs used together have been successful. Objectives are to determine the time (days) to resolution of symptoms in each treatment arm; to measure clinical relapse rates; and to assess adverse reactions related to treatment.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inpatients + outpatients diagnosed with CDAD based on SHEA definition [Laboratory confirmation for presence of C.difficile toxin using enzyme immunoassay and no other etiology for diarrhea + Presence of 1 or more of the following: diarrhea (6 watery stool over 36 hours or 3 unformed stools in 24 hours for at least 2days), pseudomembranes at endoscopy].

Exclusion Criteria:

  • Age < 14 yr
  • Known hypersensitivity to metronidazole, rifampin
  • Receiving medication(s) with potential significant drug interaction with rifampin
  • Active liver disease as indicated by ALT > 200 U/L
  • Adynamic ileus
  • Toxic megacolon
  • Pregnancy
  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: NCT00182429

Locations
Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Henderson General Hospital
Hamilton, Ontario, Canada, L8V 1C3
Sponsors and Collaborators
Hamilton Health Sciences Corporation
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Danny Lagrotteria, MD McMaster University
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00182429     History of Changes
Other Study ID Numbers: 2261, Grant Number R03-39 (PSI)
Study First Received: September 13, 2005
Last Updated: February 15, 2006
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
Antibiotic associated diarrhea
C. difficile
Metronidazole
Rifampin

Additional relevant MeSH terms:
Diarrhea
Enterocolitis
Enterocolitis, Pseudomembranous
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Metronidazole
Rifampin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014