Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment

Sponsor

McMaster University (Other)

Overall Status

Completed

CT.gov ID

NCT00182429

Collaborator

The Physicians' Services Incorporated Foundation (Other)

100

Enrollment

Locations

Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Feb 1, 2004

Actual Primary Completion Date :

Apr 30, 2005

Actual Study Completion Date :

Dec 31, 2005

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Hamilton General Hospital	Hamilton	Ontario	Canada	L8L 2X2
2	McMaster University Medical Centre	Hamilton	Ontario	Canada	L8N 3Z5
3	St. Joseph's Healthcare	Hamilton	Ontario	Canada	L8N 4A6
4	Henderson General Hospital	Hamilton	Ontario	Canada	L8V 1C3