Secondary Prevention of Clostridioides Difficile Using Vancomycin

Launched by MCGILL UNIVERSITY HEALTH CENTRE/RESEARCH INSTITUTE OF THE MCGILL UNIVERSITY HEALTH CENTRE · May 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether taking an antibiotic called oral vancomycin can help prevent Clostridioides difficile infections (CDI) from coming back in patients who are re-exposed to systemic antibiotics. Systemic antibiotics are medicines that enter the bloodstream and can disrupt the balance of good bacteria in the gut, leading to a higher chance of recurrence after a previous CDI. The trial will compare the effects of vancomycin to a placebo (a sugar pill with no active medication) in patients who have had a CDI in the last 120 days and need to take systemic antibiotics for another infection.

To participate, patients must be at least 18 years old and have had a recent episode of CDI treated with specific antibiotics. They will take the study medication twice a day while on systemic antibiotics and once a day for a week after finishing them. Participants will also attend a follow-up visit about two months later and fill out weekly questionnaires about their health. It’s important to note that the trial is not yet recruiting participants, so those interested will need to wait for it to start.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Inpatient or outpatient adults (≥18 years old) treated at the participating institutions.
• • An episode of CDI within the preceding 120 days (rationale in 2.4), diagnosed by both a positive C. difficile assay (including PCR toxin gene detection47, toxin enzyme immunoassay, and/or cell cytotoxicity neutralization assay29) and the presence of either ≥3 unformed stools in \<24 hours with a duration \>24 hours, endoscopic/histologic evidence of pseudomembranous colitis, or ileus29.
• • Treatment of the qualifying CDI episode with vancomycin or fidaxomicin for ≥10 days, clinical cure (≤3 unformed stool per 24 hours in ≥2 days10) by the conclusion of therapy, and ≥1 day has elapsed since cessation of CDI treatment.
• • Receipt of ≤3 days of at least one oral or intravenous systemic antibiotic for the treatment of an intercurrent confirmed or suspected bacterial infection, for which therapy is planned for at least one additional consecutive day in duration.
• Exclusion Criteria:
• • Treatment of the qualifying episode of CDI with metronidazole monotherapy or intravenous immunoglobulins.
• • Planned treatment with or treatment of the qualifying episode of CDI with fecal microbiota transplantation (FMT), bezlotoxumab, VOWST, or REBYOTA.
• • Inability to take medications orally or crushed by nasogastric tube.
• • Prior total colectomy.
• • Severe intolerance or allergy to oral vancomycin.
• • Lack of achievement of clinical cure during the treatment of the qualifying CDI episode
• • Ongoing or \<1 day since receiving CDI treatment or ongoing or \<1 days since receipt of CDI-active antibiotics, including oral vancomycin, oral or intravenous metronidazole, or fidaxomicin.
• • 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).
• • 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.
• • Patients admitted to a palliative care ward or is anticipated to die within 3 months of enrollment from another illness.
• • The qualifying antibiotic is non-systemic or is not considered a significant risk factor for CDI including: topical antibiotics, azithromycin, clarithromycin, nitrofurantoin, intravenous vancomycin, minocycline, tetracycline, doxycycline, and oral fosfomycin.
• • 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.