Vancomycin Taper to Prevent Recurrent Clostridioides Difficile
Initial Vancomycin Taper for the Prevention of Recurrent Clostridioides Difficile Infection 2: A Randomized Controlled Trial
McGill University Health Centre/Research Institute of the McGill University Health Centre
500 participants
Apr 24, 2026
INTERVENTIONAL
Conditions
Summary
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 fidaxomicin for the prevention of rCDI at 56 days
Eligibility
Inclusion Criteria2
- Inpatient or outpatient adults (≥18 years old) treated at the participating institutions.
- First episode or first recurrence of CDI (i.e., second episode within 56 days) defined by a positive C. difficile assay (including PCR toxin gene detection, toxin enzyme immunoassay, and/or cell cytotoxicity neutralization assay37) and the presence of either ≥3 unformed stools in <24 hours with a duration >24 hours, endoscopic/histologic evidence of pseudomembranous colitis, or ileus.
Exclusion Criteria14
- Planned or current treatment of the present episode of CDI with FMT, intravenous immunoglobulins, or other microbiome therapies (i.e., VOWST or REBYOTA).
- Inability to take medications orally or crushed by tube.
- Prior total colectomy.
- Severe intolerance or allergy to oral vancomycin or fidaxomicin.
- Patient is being admitted to a palliative care ward or is anticipated to die within 3 months of enrollment from another illness.
- Fulminant CDI, defined according to the IDSA definition of CDI with the presence of hypotension, shock, ileus, and/or toxic megacolon. This is because vancomycin is generally preferred at this severity.
- Receipt of more than 72 hours of off-study fidaxomicin or vancomycin CDI therapy for the current episode of CDI.
- Pregnancy or planning to become pregnant during the study period because minimal data on fidaxomicin in pregnancy are available.
- Active breastfeeding because minimal data on fidaxomicin in breastfeeding are available.
- Prior enrollment in this trial.
- Inability to consent without a healthcare proxy.
- Lack of health insurance.
- Anticipated transfer to a site not involved in this trial, or to a palliative care ward.
- Patient declared anticipated inability to participate in study follow-up or lack of means for contact in the outpatient setting.
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Interventions
Fidaxomicin 200mg PO BID x 10 days
Vancomycin 125mg PO QID x2 weeks, then 125mg PO BID x2 weeks, then 125mg PO daily x2 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07328971