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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

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

NCT ID

NCT00182429

First Posted

September 13, 2005

Last Updated

August 14, 2018

Sponsor

McMaster University

Collaborators

The Physicians' Services Incorporated Foundation

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

Eligibility Criteria

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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