Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment
Information source: Hamilton Health Sciences
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Clostridium Enterocolitis; Antibiotic-Associated Diarrhea; Pseudomembranous Colitis; Pseudomembranous Enterocolitis; Pseudomembranous Enteritis
Intervention: Metronidazole and Rifampin (Drug)
Phase: Phase 3
Sponsored by: Hamilton Health Sciences
Official(s) and/or principal investigator(s):
Danny Lagrotteria, MD, Principal Investigator, Affiliation: Hamilton Health Sciences
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.
Official title: Prospective, Randomized Study of Oral Metronidazole Vs. Oral Metronidazole and Rifampin for Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
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.
Minimum age: 14 Years.
Maximum age: N/A.
- 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].
- 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
Locations and Contacts
St. Joseph's Healthcare, Hamilton, Ontario L8N 4A6, Canada
McMaster University Medical Centre, Hamilton, Ontario L8N 3Z5, Canada
Hamilton General Hospital, Hamilton, Ontario L8L 2X2, Canada
Henderson General Hospital, Hamilton, Ontario L8V 1C3, Canada
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Starting date: February 2004
Ending date: April 2005
Last updated: February 15, 2006