NCT00182429

Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (planned)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clostridium Enterocolitis
• Antibiotic-Associated Diarrhea
• Pseudomembranous Colitis
• Pseudomembranous Enterocolitis
• Pseudomembranous Enteritis

Interventions

Type	Name	Description
DRUG	Metronidazole and Rifampin

Timeline

• Start date: 2004-02-01
• Primary completion: 2005-04-30
• Completion: 2005-12-31
• First posted: 2005-09-16
• Last updated: 2018-08-15

Locations

4 sites across 1 country: Canada