Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment

Phase 3

Completed

• Conditions: Antibiotic-Associated Diarrhea; Pseudomembranous Colitis; Pseudomembranous Enterocolitis; Pseudomembranous Enteritis; Clostridium Enterocolitis

• Registration Number: NCT00182429
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2005-04-30
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Study Completion: 2005-12-31
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-14
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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].

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Resolution of symptoms in each treatment arm (in days) up to 40 days (measured using daily stool and symptom diary).

Secondary Outcome Measures

Name	Time	Method
Occurrance of metronidazole resistance in the organism (C. difficile) in relapse cases.
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).

Trial Locations

Locations (4)

St. Joseph's Healthcare; 🇨🇦 Hamilton, Ontario, Canada

McMaster University Medical Centre; 🇨🇦 Hamilton, Ontario, Canada

Henderson General Hospital; 🇨🇦 Hamilton, Ontario, Canada

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada