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Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment
This study has been completed.
Study NCT00182429   Information provided by McMaster University
First Received: September 13, 2005   Last Updated: February 15, 2006   History of Changes

September 13, 2005
February 15, 2006
February 2004
 
Resolution of symptoms in each treatment arm (in days) up to 40 days (measured using daily stool and symptom diary).
Same as current
Complete list of historical versions of study NCT00182429 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
 
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)

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.

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.

Phase III
Interventional
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
  • Clostridium Enterocolitis
  • Antibiotic-Associated Diarrhea
  • Pseudomembranous Colitis
  • Pseudomembranous Enterocolitis
  • Pseudomembranous Enteritis
Drug: Metronidazole and Rifampin
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
100
April 2005
 

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
Both
14 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00182429
 
2261, Grant Number R03-39 (PSI)
Hamilton Health Sciences
The Physicians' Services Incorporated Foundation
Principal Investigator: Danny Lagrotteria, MD McMaster University
McMaster University
April 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP