Vancomycin Taper to Prevent Recurrent Clostridioides Difficile
Recruiting
Phase 3
Interventional Study
Clostridia Difficile Colitis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 500 (estimated)
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre · Other
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About This Trial
Indirect evidence from network meta-analyses of randomized controlled trials (RCTs) suggest that a pulse and taper (P-T) of vancomycin may be non-inferior to 10-days of fidaxomicin for the prevention of recurrent Clostridioides difficile infections (rCDI). The aim of this trial is:
1\) For first episodes and first recurrences of CDI, to test whether a vancomycin P-T is non-inferior to 10-days of …
Trial Locations
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Eligibility Criteria
Inclusion Criteria
1. Inpatient or outpatient adults (≥18 years old) treated at the participating institutions.
2. First episode or first recurrence of CDI (i.e., second episode within 120 days) defined by a positive C. difficile assay (including PCR toxin gene detection, toxin enzyme immunoassay, …
Contacts