Status:

COMPLETED

Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment

Lead Sponsor:

McMaster University

Collaborating Sponsors:

The Physicians' Services Incorporated Foundation

Conditions:

Clostridium Enterocolitis

Antibiotic-Associated Diarrhea

Eligibility:

All Genders

14+ years

Phase:

PHASE3

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 diarrhe...

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 oc...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

February 1 2004

Trial Type :

INTERVENTIONAL

End Date :

December 31 2005

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00182429

Start Date

February 1 2004

End Date

December 31 2005

Last Update

August 15 2018

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Hamilton General Hospital

Hamilton, Ontario, Canada, L8L 2X2

2

McMaster University Medical Centre

Hamilton, Ontario, Canada, L8N 3Z5

3

St. Joseph's Healthcare

Hamilton, Ontario, Canada, L8N 4A6

4

Henderson General Hospital

Hamilton, Ontario, Canada, L8V 1C3