RecruitingPhase 2Phase 3NCT06979609

Secondary Prevention of Clostridioides Difficile Using Vancomycin

Secondary Prophylaxis of Recurrent Clostridioides Difficile Infections During Systemic Antibiotics With Vancomycin: A Randomized Controlled Trial


Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrollment

300 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Re-exposure to systemic antibiotics (i.e., antibiotics absorbed into the bloodstream) is common after a Clostridioides difficile infection (CDI) and is the strongest risk factor for a recurrent episode. Oral vancomycin to prevent a recurrence during antibiotic re-exposure may reduce this risk but the data supporting this practice are limited. The aim of this trial is: 1\) Does oral vancomycin prophylaxis prevent CDI recurrences in patients with recent CDI (within 120 days) and who are re-exposed to systemic antibiotics? The trial will compare oral vancomycin to placebo. Participants will: * Take the study drug (either vancomycin or placebo) twice daily for the duration of systemic antibiotics plus once daily for 7 days after completion of systemic antibiotics. * Attend an in-person or over the phone follow-up at day 56 * Respond to weekly electronic questionnaires


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Oral Vancomycin Prophylaxis and a drug called Placebo for people with clostridioides difficile infection, clostridioides difficile infection recurrence, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOral Vancomycin Prophylaxis

125mg PO BID for the duration of antibiotic re-exposure + 125mg PO QD for 7 days

DRUGPlacebo

2 capsules PO BID for the duration of antibiotic re-exposure + 1 capsule PO QD x 7 days


Locations(1)

McGill University Health Centre

Montreal, Quebec, Canada

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NCT06979609


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