Vancomycin pulse-and-taper versus 10-day fidaxomicin to prevent recurrent C. difficile
Official title: Initial Vancomycin Taper for the Prevention of Recurrent Clostridioides Difficile Infection 2: A Randomized Controlled Trial
Run by McGill University Health Centre/Research Institute of the McGill University Health Centre · NCT07328971 · Data updated 2026-11-12
This trial tests whether a vancomycin pulse-and-taper schedule works as well as a 10-day course of fidaxomicin to prevent recurrence in adults with a first episode or first recurrence of C. difficile.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 2 sites (Edmonton, Alberta and 1 other locations) |
| Status | Recruiting |
| Started | April 24, 2026 |
| Main results expected | June 1, 2030 |
| Study ends | November 1, 2030 |
| Registry record updated | September 23, 2026 |
| Trial ID | NCT07328971 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with a confirmed first episode or first recurrence of C. difficile infection who meet the study's diagnostic criteria and local reimbursement eligibility are the ideal candidates.
✕Probably not a fit
Patients with multiple prior recurrences (multiply recurrent CDI) or those who do not meet local fidaxomicin reimbursement criteria may not be represented and therefore may not receive direct benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with a first episode or first recurrence of Clostridioides difficile infection will be assigned to receive either a vancomycin pulse-and-taper regimen or a 10-day course of fidaxomicin and followed for recurrence through day 56. The primary objective is to show non-inferiority of vancomycin P-T compared with fidaxomicin for preventing recurrent CDI at 56 days. Diagnosis requires a positive C. difficile assay plus compatible symptoms, and local fidaxomicin reimbursement criteria will be applied until dedicated funding is available. This phase 3 interventional comparison is conducted at the McGill University Health Centre in Montreal.
Why it matters
Potential benefit: If successful, an inexpensive vancomycin pulse-and-taper could prevent recurrences as effectively as fidaxomicin, improving access and reducing treatment costs.
How similar studies have gone: Network meta-analyses and indirect evidence suggest pulse-and-taper vancomycin may be non-inferior to fidaxomicin, but direct head-to-head randomized evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion 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, 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 1. Treatment with CDI-active antibiotics that will be continued throughout the trial (i.e., rifaximin for hepatic encephalopathy). 2. Planned or current treatment of the present episode of CDI with FMT, intravenous immunoglobulins, or other microbiome therapies (i.e., VOWST or REBYOTA). 3. Inability to take medications orally. 4. Ileostomy, colostomy, or total colectomy with ileorectal anastomosis. 5. Severe intolerance or allergy to oral vancomycin or fidaxomicin. 6. The patient is being admitted to a palliative care ward or is anticipated to die within 3 months of enrollment from another illness. 7. Fulminant CDI, defined according to the IDSA definition of CDI with the presence of hypotension, shock, ileus, and/or toxic megacolon. 8. Receipt of more than 72 hours of off-study fidaxomicin or vancomycin CDI therapy for the current episode of CDI. 9. Pregnancy or planning to become pregnant during the study period because minimal data on fidaxomicin in pregnancy are available. 10. Active breastfeeding because minimal data on fidaxomicin in breastfeeding are available. 11. Patients who have had ≥3 episodes of CDI in the last 1 year. 12. Treating team declined participation. 13. Prior enrolment in TAPER-V2. Administrative Exclusion Criteria 1. Prior enrollment in this trial. 2. Inability to consent without a healthcare proxy. 3. Lack of health insurance. 4. Anticipated transfer to a site not involved in this trial, or to a palliative care ward 5. Patient-declared anticipated inability to participate in study follow-up or lack of means for contact in the outpatient setting.
Where it's running
-
University of Alberta
Edmonton, Alberta, Canada Recruiting -
McGill University Health Centre
Montreal, Quebec, Canada Recruiting
Study contacts
- Principal investigator: Emily McDonald, MD MSc — McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study coordinator: Connor Prosty, MD
- Email: connor.prosty@mail.mcgill.ca
- Phone: 514-934-1934
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.