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NCT06979609: SPORES-V

Secondary Prevention of Clostridioides Difficile Using Vancomycin

Recruiting now Phase 2, PHASE3 Last updated 19 September 2025
What this trial tests

Phase 2, PHASE3 trial testing Oral Vancomycin Prophylaxis in Clostridioides Difficile Infection in 300 participants. Currently enrolling.

Timeline
1 October 2025
Primary endpoint
1 October 2028
1 October 2029

Quick facts

Lead sponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre
PhasePhase 2, PHASE3
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment300
Start date1 October 2025
Primary completion1 October 2028
Estimated completion1 October 2029
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

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

Who can join

18 and older, any sex, with Clostridioides Difficile Infection or Clostridioides Difficile Infection Recurrence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 follow-up at day 56 * Respond to weekly electronic questionnaires

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Clostridioides Difficile Infection

Currently open trials in the same condition.

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

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing