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Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment

Primary Purpose

Clostridium Enterocolitis, Antibiotic-Associated Diarrhea, Pseudomembranous Colitis

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Metronidazole and Rifampin
Sponsored by
McMaster University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Enterocolitis focused on measuring Antibiotic associated diarrhea, C. difficile, Metronidazole, Rifampin

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hamilton General Hospital
  • McMaster University Medical Centre
  • St. Joseph's Healthcare
  • Henderson General Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
September 13, 2005
Last Updated
August 14, 2018
Sponsor
McMaster University
Collaborators
The Physicians' Services Incorporated Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00182429
Brief Title
Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment
Official Title
Prospective, Randomized Study of Oral Metronidazole vs. Oral Metronidazole and Rifampin for Treatment of Clostridium Difficile-associated Diarrhea (CDAD)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
April 30, 2005 (Actual)
Study Completion Date
December 31, 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
McMaster University
Collaborators
The Physicians' Services Incorporated Foundation

4. Oversight

5. Study Description

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 Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Enterocolitis, Antibiotic-Associated Diarrhea, Pseudomembranous Colitis, Pseudomembranous Enterocolitis, Pseudomembranous Enteritis
Keywords
Antibiotic associated diarrhea, C. difficile, Metronidazole, Rifampin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Metronidazole and Rifampin
Primary Outcome Measure Information:
Title
Resolution of symptoms in each treatment arm (in days) up to 40 days (measured using daily stool and symptom diary).
Secondary Outcome Measure Information:
Title
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).
Title
Adverse reactions related to treatment within 40 days (measured using daily symptom diary and interviewing patient).
Title
Occurrance of metronidazole resistance in the organism (C. difficile) in relapse cases.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine H Lee, MD
Organizational Affiliation
McMaster University
Official's Role
Study Director
Facility Information:
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
St. Joseph's Healthcare
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Henderson General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
3571889
Citation
Buggy BP, Fekety R, Silva J Jr. Therapy of relapsing Clostridium difficile-associated diarrhea and colitis with the combination of vancomycin and rifampin. J Clin Gastroenterol. 1987 Apr;9(2):155-9. doi: 10.1097/00004836-198704000-00009.
Results Reference
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PubMed Identifier
8722937
Citation
Wenisch C, Parschalk B, Hasenhundl M, Hirschl AM, Graninger W. Comparison of vancomycin, teicoplanin, metronidazole, and fusidic acid for the treatment of Clostridium difficile-associated diarrhea. Clin Infect Dis. 1996 May;22(5):813-8. doi: 10.1093/clinids/22.5.813. Erratum In: Clin Infect Dis 1996 Aug;23(2):423.
Results Reference
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PubMed Identifier
4043661
Citation
Young GP, Ward PB, Bayley N, Gordon D, Higgins G, Trapani JA, McDonald MI, Labrooy J, Hecker R. Antibiotic-associated colitis due to Clostridium difficile: double-blind comparison of vancomycin with bacitracin. Gastroenterology. 1985 Nov;89(5):1038-45. doi: 10.1016/0016-5085(85)90206-9.
Results Reference
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PubMed Identifier
7632199
Citation
Olson MM, Shanholtzer CJ, Lee JT Jr, Gerding DN. Ten years of prospective Clostridium difficile-associated disease surveillance and treatment at the Minneapolis VA Medical Center, 1982-1991. Infect Control Hosp Epidemiol. 1994 Jun;15(6):371-81. doi: 10.1086/646934.
Results Reference
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PubMed Identifier
3521518
Citation
Dudley MN, McLaughlin JC, Carrington G, Frick J, Nightingale CH, Quintiliani R. Oral bacitracin vs vancomycin therapy for Clostridium difficile-induced diarrhea. A randomized double-blind trial. Arch Intern Med. 1986 Jun;146(6):1101-4.
Results Reference
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PubMed Identifier
6138597
Citation
Teasley DG, Gerding DN, Olson MM, Peterson LR, Gebhard RL, Schwartz MJ, Lee JT Jr. Prospective randomised trial of metronidazole versus vancomycin for Clostridium-difficile-associated diarrhoea and colitis. Lancet. 1983 Nov 5;2(8358):1043-6. doi: 10.1016/s0140-6736(83)91036-x.
Results Reference
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PubMed Identifier
10543736
Citation
Barbut F, Decre D, Burghoffer B, Lesage D, Delisle F, Lalande V, Delmee M, Avesani V, Sano N, Coudert C, Petit JC. Antimicrobial susceptibilities and serogroups of clinical strains of Clostridium difficile isolated in France in 1991 and 1997. Antimicrob Agents Chemother. 1999 Nov;43(11):2607-11. doi: 10.1128/AAC.43.11.2607.
Results Reference
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PubMed Identifier
1444298
Citation
de Lalla F, Nicolin R, Rinaldi E, Scarpellini P, Rigoli R, Manfrin V, Tramarin A. Prospective study of oral teicoplanin versus oral vancomycin for therapy of pseudomembranous colitis and Clostridium difficile-associated diarrhea. Antimicrob Agents Chemother. 1992 Oct;36(10):2192-6. doi: 10.1128/AAC.36.10.2192.
Results Reference
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Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment

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