Actively Recruiting
Vancomycin Taper to Prevent Recurrent Clostridioides Difficile
Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2026-04-30
500
Participants Needed
1
Research Sites
236 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Vancomycin Taper to Prevent Recurrent Clostridioides Difficile
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
- Because of the prohibitive cost of fidaxomicin, the reimbursement criteria of fidaxomicin by the Régie de l'assurance maladie du Québec will be applied as inclusion criteria until dedicated fidaxomicin funding is available. This includes: either 1) ≥65 years old or immunosuppression, 2) a second episode of C. difficile within 12 weeks of a prior episode of C. difficile, or 3) multiply recurrent CDI (i.e., ≥2 recurrences). When additional funding is obtained, then only inclusion criteria 1 and 2 will be applied.
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 1 location
1
McGill University Health Centre
Montreal, Quebec, Canada, H4A0B1
Actively Recruiting
Research Team
C
Connor Prosty, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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