Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment

• Status: Completed
• Trial end date: 2005-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Collaborator: The Physicians' Services Incorporated Foundation
• Treatments: Metronidazole; Rifampin

Criteria

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