Vancomycin Taper to Prevent Recurrent Clostridioides Difficile

Recruiting now · Phase 3

Conditions studied: Clostridia Difficile Colitis

In brief

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

Key facts

Study ID

NCT07328971

Run by

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

People needed

500

Starts

2026-04-24

Expected to finish

2030-11-01

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inpatient or outpatient adults (≥18 years old) treated at the participating institutions.
• 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, and/or cell cytotoxicity neutralization assay) and the presence of either ≥3 unformed stools in <24 hours with a duration >24 hours, endoscopic/histologic evidence of pseudomembranous colitis, or ileus. For eligibility, CDI will be considered a first recurrence if the patient experiences 2 episodes within a 120-day timeframe; those with a first ever episode, or 2 episodes separated by more than 120 days, will be categorized as a first-episode.
• Clinical Exclusion Criteria
• Treatment with CDI-active antibiotics that will be continued throughout the trial (i.e., rifaximin for hepatic encephalopathy).
• 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.
• Ileostomy, colostomy, or total colectomy with ileorectal anastomosis.
• Severe intolerance or allergy to oral vancomycin or fidaxomicin.
• The 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.
• 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.
• Patients who have had ≥3 episodes of CDI in the last 1 year.
• Treating team declined participation.
• Prior enrolment in TAPER-V2.
• Administrative Exclusion Criteria
• 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.

Where it is running

• McGill University Health Centre — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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