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Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
ID06979609

Preventing Recurrence of Clostridioides Difficile Infection with Oral Vancomycin During Antibiotic Treatment A Randomized Controlled Trial

Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2026-06-24

300

Participants Needed

1

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether oral vancomycin can prevent recurrent Clostridioides difficile infections CDI in adults who recently had CDI and are exposed again to systemic antibiotics. This is a randomized, double-blind trial comparing vancomycin prophylaxis to placebo. CDI causes severe diarrhea and has a high rate of recurrence, leading to significant health risks and economic costs. Antibiotic re-exposure is a major risk factor for recurrence, and this study aims to determine if vancomycin given during antibiotic use reduces that risk. Participants will take either oral vancomycin or placebo capsules twice daily during the course of systemic antibiotic treatment and then once daily for seven days after finishing antibiotics. The trial includes two groups one receiving vancomycin 125mg and the other receiving placebo capsules matching the dosing schedule. The study drug is taken orally, and the treatment period matches the duration of antibiotic use plus an additional week. During the study, participants will attend a follow-up visit in person or by phone at day 56 and complete weekly electronic questionnaires. Researchers will monitor CDI recurrence up to 56 days as the primary outcome and also track late recurrence, mortality, emergency visits, hospital admissions, adverse events, and drug discontinuation. The study aims to provide clear evidence on vancomycins role in preventing recurrent CDI during antibiotic re-exposure, with participation expected to last several months.

CONDITIONS

Brief Title

Secondary Prevention of Clostridioides Difficile Using Vancomycin

Research Team

E

Emily G. McDonald, MD MSc

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