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Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment

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: NCT00182429
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : August 15, 2018
The Physicians' Services Incorporated Foundation
Information provided by:
McMaster University

Brief Summary:
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 or disease Intervention/treatment Phase
Clostridium Enterocolitis Antibiotic-Associated Diarrhea Pseudomembranous Colitis Pseudomembranous Enterocolitis Pseudomembranous Enteritis Drug: Metronidazole and Rifampin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Prospective, Randomized Study of Oral Metronidazole vs. Oral Metronidazole and Rifampin for Treatment of Clostridium Difficile-associated Diarrhea (CDAD)
Study Start Date : February 2004
Actual Primary Completion Date : April 30, 2005
Actual Study Completion Date : December 31, 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

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

Secondary Outcome Measures :
  1. 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).
  2. Adverse reactions related to treatment within 40 days (measured using daily symptom diary and interviewing patient).
  3. Occurrance of metronidazole resistance in the organism (C. difficile) in relapse cases.

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00182429

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Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Henderson General Hospital
Hamilton, Ontario, Canada, L8V 1C3
Sponsors and Collaborators
McMaster University
The Physicians' Services Incorporated Foundation
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Study Director: Christine H Lee, MD McMaster University


Layout table for additonal information Identifier: NCT00182429     History of Changes
Other Study ID Numbers: 2261
Grant Number R03-39 (PSI)
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Keywords provided by McMaster University:
Antibiotic associated diarrhea
C. difficile
Additional relevant MeSH terms:
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Enterocolitis, Pseudomembranous
Anti-Infective Agents
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers