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Prevention study for Clostridioides Difficile Infection
Official title Secondary Prevention of Clostridioides Difficile Using Vancomycin
ClinicalTrials.gov ID: NCT06979609
What this study is testing
What is Oral Vancomycin Prophylaxis?
Oral Vancomycin Prophylaxis is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for clostridioides difficile infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Re-exposure to systemic antibiotics (i.e., antibiotics absorbed into the bloodstream) is common after a Clostridioides difficile infection (CDI) and is the strongest risk factor for a recurrent episode. Oral vancomycin to prevent a recurrence during antibiotic re-exposure may reduce this risk but the data supporting this practice are limited.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Inpatient or outpatient adults (≥18 years old) treated at the participating institutions.
- An episode of CDI within the preceding 120 days, diagnosed by both a positive C. difficile assay (including PCR toxin gene detection, toxin enzyme...
- Treatment of the qualifying CDI episode with vancomycin or fidaxomicin for ≥10 days, and achievement of clinical cure (≤3 unformed stool per 24 hours...
- 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...
You likely can't join if
- ≥72 hours of off-study vancomycin prophylaxis for the current episode of antibiotic re-exposure.
- ≤1 day elapsed since discontinuation of CDI treatment
- 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, REBYOTA, or...
- Inability to take medications orally.
- Ileostomy, colostomy, or total colectomy with ileorectal anastomosis.
See the full eligibility criteria
- Inpatient or outpatient adults (≥18 years old) treated at the participating institutions.
- 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...
- 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).
- 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
- ≥72 hours of off-study vancomycin prophylaxis for the current episode of antibiotic re-exposure.
- ≤1 day elapsed since discontinuation of CDI treatment
- 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, REBYOTA, or another microbiome agent.
- Inability to take medications orally.
- Ileostomy, colostomy, or total colectomy with ileorectal anastomosis.
- Severe intolerance or allergy to oral vancomycin.
- Lack of achievement of clinical cure during the treatment of the qualifying CDI episode
- 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...
- 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 who are anticipated to die within 8 weeks of enrollment from another illness.
- 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...
- Concomitant receipt of rifaximin (e.g., for hepatic encephalopathy).
- Receipt of ≥2 courses of vancomycin prophylaxis since the qualifying episode of CDI or \<2 weeks since the last course of vancomycin prophylaxis.
- Treating team declined participation. Administrative Exclusion Criteria
- Prior enrollment in this trial.
- Inability to consent and 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.
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.