Prospective, Randomized Study of Oral Metronidazole vs. Oral Metronidazole and Rifampin for Treatment of Clostridium Difficile-associated Diarrhea (CDAD)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- McMaster University
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- Resolution of symptoms in each treatment arm (in days) up to 40 days (measured using daily stool and symptom diary).
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 14 Years to — (Child, Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Resolution of symptoms in each treatment arm (in days) up to 40 days (measured using daily stool and symptom diary).
Secondary Outcomes
- 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.