Clinical Trial

Secondary Prevention of Clostridioides Difficile Using Vancomycin

Study acronym: SPORES-V
Recruiting Phase 2/3
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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
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-05-13; most recent amendment 2026-06-19.
Status change: Not Yet Recruiting → Recruiting 2025-09-15
Trial Details
NCT Number NCT06979609
Lead Sponsor McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions Clostridioides Difficile Infection, Clostridioides Difficile Infection Recurrence, Clostridoides Difficile Associated Disease
Enrollment 300 participants
Start Date 2025-11-01
Primary Completion 2028-10-01 (estimated)
Study Completion 2029-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-24