Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Clostridium Enterocolitis Antibiotic-Associated Diarrhea Pseudomembranous Colitis Pseudomembranous Enterocolitis Pseudomembranous Enteritis |
Drug: Metronidazole and Rifampin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Prospective, Randomized Study of Oral Metronidazole Vs. Oral Metronidazole and Rifampin for Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) |
- Resolution of symptoms in each treatment arm (in days) up to 40 days (measured using daily stool and symptom diary).
- 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.
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2004 |
| Estimated Study Completion Date: | April 2005 |
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.
Eligibility| Ages Eligible for Study: | 14 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Canada, Ontario | |
| St. Joseph's Healthcare | |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| McMaster University Medical Centre | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Hamilton General Hospital | |
| Hamilton, Ontario, Canada, L8L 2X2 | |
| Henderson General Hospital | |
| Hamilton, Ontario, Canada, L8V 1C3 | |
| Principal Investigator: | Danny Lagrotteria, MD | McMaster University |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00182429 History of Changes |
| Other Study ID Numbers: | 2261, Grant Number R03-39 (PSI) |
| Study First Received: | September 13, 2005 |
| Last Updated: | February 15, 2006 |
| Health Authority: | Canada: Health Canada |
Keywords provided by McMaster University:
|
Antibiotic associated diarrhea C. difficile Metronidazole Rifampin |
Additional relevant MeSH terms:
|
Colitis Diarrhea Enteritis Enterocolitis Enterocolitis, Pseudomembranous Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Signs and Symptoms, Digestive Signs and Symptoms Clostridium Infections Gram-Positive Bacterial Infections Bacterial Infections |
Metronidazole Rifampin Radiation-Sensitizing Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Infective Agents Therapeutic Uses Antiprotozoal Agents Antiparasitic Agents Antibiotics, Antitubercular Anti-Bacterial Agents Antitubercular Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Leprostatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013