Vancomycin Taper to Prevent Recurrent Clostridioides Difficile

Initial Vancomycin Taper for the Prevention of Recurrent Clostridioides Difficile Infection 2: A Randomized Controlled Trial

Vancomycin Taper to Prevent Recurrent Clostridioides Difficile (NCT07328971) is a Phase 3 interventional studying Clostridia Difficile Colitis, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Clostridia Difficile Colitis, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 500 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Treatments Being Tested

DRUG

Fidaxomicin

Fidaxomicin 200mg PO BID x 10 days

DRUG

Vancomycin capsule

Vancomycin 125mg PO QID x2 weeks, then 125mg PO BID x2 weeks, then 125mg PO daily x2 weeks

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

McGill University Health Centre

Montreal, Quebec, Canada

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07328971), the sponsor (McGill University Health Centre/Research Institute of the McGill University Health Centre), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07328971 clinical trial studying?

Who can participate in NCT07328971?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07328971?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07328971. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07328971. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.