Clinical Trial: Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: McMaster University

Current Primary Outcome: Resolution of symptoms in each treatment arm (in days) up to 40 days (measured using daily stool and symptom diary).

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: McMaster University

Dates:
Date Received: September 13, 2005
Date Started: February 2004
Date Completion: April 2005
Last Updated: April 12, 2016
Last Verified: April 2016