Can a simple vancomycin taper beat a pricey drug for recurrent c. diff?
NCT ID NCT07328971
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether a gradual taper of vancomycin is as good as a 10-day course of fidaxomicin at preventing another C. difficile infection. About 500 adults with a first or second C. diff episode will be randomly assigned to one of the two treatments. The main goal is to see how many people have a repeat infection within 56 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- vancomycin and fidaxomicin
- What this could lead to
- If successful, this could offer a cheaper, simpler way to prevent repeat C. difficile infections, reducing hospital visits and improving quality of life.
- What could go wrong
- This is a non-inferiority trial, so even if vancomycin works, it may not be better than the current standard. Results may not apply to all patients or settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Nov 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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McGill University Health Centre
RECRUITINGMontreal, Quebec, H4A0B1, Canada
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