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Secondary Prevention of Clostridioides Difficile Using Vancomycin

NCT06979609 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-09-19

No results posted yet for this study

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

Conditions

  • Clostridioides Difficile Infection
  • Clostridioides Difficile Infection Recurrence
  • Clostridoides Difficile Associated Disease

Interventions

DRUG

Oral Vancomycin Prophylaxis

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

DRUG

Placebo

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

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Todd C. Lee, MD MPH · McGill University Health Centre/Research Institute of the McGill University Health Centre

  • Connor J. Prosty, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2028-10-01
Completion
2029-10-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06979609 on ClinicalTrials.gov