Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment
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|ClinicalTrials.gov Identifier: NCT00182429|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : August 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Enterocolitis Antibiotic-Associated Diarrhea Pseudomembranous Colitis Pseudomembranous Enterocolitis Pseudomembranous Enteritis||Drug: Metronidazole and Rifampin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|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|
- Resolution of symptoms in each treatment arm (in days) up to 40 days (measured using daily stool and symptom diary).
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT00182429
|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|
|Study Director:||Christine H Lee, MD||McMaster University|