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NCT Number: NCT00182429

Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment

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.

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Key information

Conditions

Clostridium Enterocolitis Antibiotic-associated Diarrhea Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Digestive System Diseases Enterocolitis Enterocolitis, Pseudomembranous Gastroenteritis Gastrointestinal Diseases Gram-Positive Bacterial Infections Infections Intestinal Diseases Pseudomembranous Colitis Pseudomembranous Enteritis Pseudomembranous Enterocolitis

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hamilton General Hospital, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metronidazole and Rifampin

Drug

Primary outcomes

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

Secondary outcomes

  1. 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).

  2. Adverse reactions related to treatment within 40 days (measured using daily symptom diary and interviewing patient).

  3. Occurrance of metronidazole resistance in the organism (C. difficile) in relapse cases.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • The Physicians' Services Incorporated Foundation

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 16, 2005
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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