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Sponsors and Collaborators: |
Hamilton Health Sciences The Physicians' Services Incorporated Foundation |
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Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | NCT00182429 |
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 |
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Clostridium Enterocolitis Antibiotic-Associated Diarrhea Pseudomembranous Colitis Pseudomembranous Enterocolitis Pseudomembranous Enteritis |
Drug: Metronidazole and Rifampin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective, Randomized Study of Oral Metronidazole Vs. Oral Metronidazole and Rifampin for Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) |
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.
Ages Eligible for Study: | 14 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | 2261, Grant Number R03-39 (PSI) |
Study First Received: | September 13, 2005 |
Last Updated: | February 15, 2006 |
ClinicalTrials.gov Identifier: | NCT00182429 History of Changes |
Health Authority: | Canada: Health Canada |
Antibiotic associated diarrhea C. difficile Metronidazole Rifampin |
Bacterial Infections Metronidazole Anti-Infective Agents Crohn's Disease Signs and Symptoms, Digestive Gastrointestinal Diseases Colonic Diseases Enterocolitis, Pseudomembranous Enterocolitis Signs and Symptoms Anti-Bacterial Agents Rifampin Gram-Positive Bacterial Infections |
Diarrhea Ileitis Enteritis Clostridium Difficile Intestinal Diseases Digestive System Diseases Radiation-Sensitizing Agents Crohn Disease Antitubercular Agents Gastroenteritis Clostridium Infections Colitis |
Bacterial Infections Metronidazole Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Signs and Symptoms, Digestive Gastrointestinal Diseases Colonic Diseases Physiological Effects of Drugs Enterocolitis, Pseudomembranous Enterocolitis Anti-Bacterial Agents Signs and Symptoms Rifampin Gram-Positive Bacterial Infections |
Antiparasitic Agents Therapeutic Uses Nucleic Acid Synthesis Inhibitors Diarrhea Enteritis Enzyme Inhibitors Intestinal Diseases Pharmacologic Actions Antibiotics, Antitubercular Digestive System Diseases Radiation-Sensitizing Agents Antitubercular Agents Clostridium Infections Gastroenteritis Colitis |