Initial Vancomycin Taper for the Prevention of Recurrent Clostridium Difficile Infection
Status:
Recruiting
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
Summary
The first line therapy for an initial episode of CDI (Clostridium difficile infection) is
10-14 days of oral vancomycin which is now recommended over metronidazole in the 2018
guidelines from the Association of Medical Microbiologists and Infectious Diseases of Canada
(AMMI). Although response rates for the treatment of a first episode of CDI now approach 90%,
approximately 25% of patients who have a complete response will develop recurrence (rCDI)
within 8 weeks. Doctors' ability to predict recurrence is evolving, but remains very limited.
The investigators hypothesize that by extending initial vancomycin therapy with a 2-week
tapering regimen this will reduce the risk of rCDI. Starting at the end of the initial 14
days of therapy, participants will be randomized to receive an additional 14-days of placebo
or vancomycin taper (125 mg orally twice daily x 7 days followed by 125 mg orally once daily
x 7 days). This taper was chosen as it represents two steps of a commonly used 4-week
vancomycin taper.
The investigators' proposal to evaluate the extension of initial treatment from 14 to 28 days
with a tapering dose of vancomycin represents a practical clinical trial that capitalizes on
oral vancomycin's safety profile, worldwide availability, and relatively low cost.
Phase:
Phase 4
Details
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre Todd Lee