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Secondary Prevention of Clostridioides Difficile Using Vancomycin

Study acronym: SPORES-V
StatusRecruiting
PhasePhase 2/3
Started
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Record History

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  1. Start date changed from estimate of Oct 1, 2025 to Nov 1, 2025
    • Eligibility criteria expanded, about 49 words
    • Secondary endpoints: 4 to 5
    v3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Primary completion date: Dec 1, 2028 to Oct 1, 2028
    • Study completion date: Jun 30, 2029 to Oct 1, 2029
    • Start date: Dec 1, 2025 to Oct 1, 2025
    • Secondary endpoints: details revised at 3 of 4 entries
    • Site details revised
    • Study description expanded, about 1 word
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06979609
Lead Sponsor McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions
(from sponsor)		 Clostridioides Difficile Infection, Clostridioides Difficile Infection Recurrence, Clostridoides Difficile Associated Disease
Related terms Clostridium Infections, Recurrence
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov