Can a common antibiotic stop c. diff from coming back?
NCT ID NCT06979609
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether taking oral vancomycin while on other antibiotics can prevent a repeat Clostridioides difficile infection (CDI) in people who had one in the last 120 days. Researchers will compare vancomycin to a placebo in 300 adults. Participants take the study drug twice daily during antibiotic treatment and for 7 days after, then are followed for 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
- What this could lead to
- If it works, this could provide a simple way to prevent repeat C. diff infections in patients who need other antibiotics.
- What could go wrong
- This is a mid-stage trial, so results are not yet proven. Vancomycin may not reduce recurrence and could contribute to antibiotic resistance.
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
-
Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
-
About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2025
- Expected to finish
-
Oct 2029
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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. An episode of CDI within the preceding 120 days, diagnosed by both 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. 3. Treatment of the qualifying CDI episode with vancomycin or fidaxomicin for ≥10 days, and achievement of clinical cure (≤3 unformed stool per 24 hours in ≥2 days10). 4. Receipt of ≤3 days of at least one oral or intravenous systemic antibiotic, for which therapy is planned for at least one additional consecutive day in duration. Clinical Exclusion Criteria 1. ≥72 hours of off-study vancomycin prophylaxis for the current episode of antibiotic re-exposure. 2. ≤1 day elapsed since discontinuation of CDI treatment 3. Treatment of the qualifying episode of CDI with metronidazole monotherapy or intravenous immunoglobulins. 4. Planned treatment with or treatment of the qualifying episode of CDI with fecal microbiota transplantation (FMT), bezlotoxumab, VOWST, REBYOTA, or another microbiome agent. 5. Inability to take medications orally. 6. Ileostomy, colostomy, or total colectomy with ileorectal anastomosis. 7. Severe intolerance or allergy to oral vancomycin. 8. Lack of achievement of clinical cure during the treatment of the qualifying CDI episode 9. The qualifying antibiotic is solely for prophylaxis (e.g., once daily trimethoprim sulfamethoxazole) or the patient is anticipated to require systemic antibiotics for \>4 weeks (e.g., lifelong suppressive therapy or for the treatment of left-sided endocarditis or a deep-seated abscess). 10. Patients on ongoing systemic antibiotics since the completion of treatment for the qualifying episode of CDI that have not been interrupted by at least one day. 11. Patients admitted to a palliative care ward or who are anticipated to die within 8 weeks of enrollment from another illness. 12. The qualifying antibiotic is non-systemic (i.e., topical) or is not considered a significant risk factor for CDI including: single-dose antibiotics, as well as macrolides, nitrofurantoin, intravenous vancomycin, metronidazole, tetracyclines, and oral fosfomycin. If two or more systemic antibiotics are given (i.e., ceftriaxone and azithromycin), as long as at least one of the systemic antibiotics does not meet exclusion criteria, then the patient will still be eligible. 13. Concomitant receipt of rifaximin (e.g., for hepatic encephalopathy). 14. Receipt of ≥2 courses of vancomycin prophylaxis since the qualifying episode of CDI or \<2 weeks since the last course of vancomycin prophylaxis. 15. Treating team declined participation. Administrative Exclusion Criteria 1. Prior enrollment in this trial. 2. Inability to consent and 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Clostridioides difficile infection are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
McGill University Health Centre
RECRUITINGMontreal, Quebec, H4A3J1, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a potato starch shake off Drug-Resistant gut bacteria?
- Your dinner plate might fight c. diff: diet study aims to stop repeat infections
- FMT vs antibiotics: which works better Long-Term for c. diff?
- Hospital maps may slash infection spread
- New antibiotic CRS3123 takes on c. diff in early trial
- Gut bacteria capsules take on superbugs in antibiotic patients