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NCT06979609: SPORES-V
Secondary Prevention of Clostridioides Difficile Using Vancomycin
Phase 2, PHASE3 trial testing Oral Vancomycin Prophylaxis in Clostridioides Difficile Infection in 300 participants. Currently enrolling.
1 October 2028
Quick facts
| Lead sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 300 |
| Start date | 1 October 2025 |
| Primary completion | 1 October 2028 |
| Estimated completion | 1 October 2029 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Oral Vancomycin Prophylaxis — full drug profile →
- Placebo
Conditions studied
- Clostridioides Difficile Infection — all drugs for Clostridioides Difficile Infection →
- Clostridioides Difficile Infection Recurrence — all drugs for Clostridioides Difficile Infection Recurrence →
- Clostridoides Difficile Associated Disease — all drugs for Clostridoides Difficile Associated Disease →
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.
Verify or expand the search:
- PubMed search for NCT06979609
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT06788769 — Study of Clostridioides Difficile in Infants · recruiting
- NCT06306014 — Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in Hi · Phase 1, PHASE2 · recruiting
Other McGill University Health Centre/Research Institute of the McGill University Health Centre trials
Trials by the same sponsor.
- NCT07439406 — Comparing Standard and Autoclaved Peanut Oral Immunotherapy in People With Peanut Allergy · Phase 2 · not yet recruiting
- NCT07328971 — Vancomycin Taper to Prevent Recurrent Clostridioides Difficile · Phase 3 · not yet recruiting
- NCT07556952 — Dex & Mastectomy Pain · Phase 4 · recruiting
- NCT07069582 — Pharmacokinetics of Antituberculosis Drugs in Breastfeeding Women · Phase 1 · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06979609 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre
- Last refreshed: 19 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06979609.
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