Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment
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.
Drug: Metronidazole and Rifampin
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Prospective, Randomized Study of Oral Metronidazole Vs. Oral Metronidazole and Rifampin for Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)|
- 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.
|Study Start Date:||February 2004|
|Estimated Study Completion Date:||April 2005|
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.
|St. Joseph's Healthcare|
|Hamilton, Ontario, Canada, L8N 4A6|
|McMaster University Medical Centre|
|Hamilton, Ontario, Canada, L8N 3Z5|
|Hamilton General Hospital|
|Hamilton, Ontario, Canada, L8L 2X2|
|Henderson General Hospital|
|Hamilton, Ontario, Canada, L8V 1C3|
|Principal Investigator:||Danny Lagrotteria, MD||McMaster University|