Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective, Randomized Study of Oral Metronidazole vs. Oral Metronidazole and Rifampin for Treatment of Clostridium Difficile-associated Diarrhea (CDAD)

Conditions
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Clostridium Enterocolitis, Antibiotic-Associated Diarrhea, Pseudomembranous Colitis, Pseudomembranous Enterocolitis, Pseudomembranous Enteritis

Intervention / Treatment
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* Drug: Metronidazole and Rifampin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Metronidazole and Rifampin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of symptoms in each treatment arm (in days) up to 40 days (measured using daily stool and symptom diary). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibiotic associated diarrhea, C. difficile, Metronidazole, Rifampin