Actively Recruiting
Secondary Prevention of Clostridioides Difficile Using Vancomycin
Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2025-09-19
300
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. The aim of this trial is: 1\) Does oral vancomycin prophylaxis prevent CDI recurrences in patients with recent CDI (within 120 days) and who are re-exposed to systemic antibiotics? The trial will compare oral vancomycin to placebo. Participants will: * Take the study drug (either vancomycin or placebo) twice daily for the duration of systemic antibiotics plus once daily for 7 days after completion of systemic antibiotics. * Attend an in-person follow-up at day 56 * Respond to weekly electronic questionnaires
CONDITIONS
Official Title
Secondary Prevention of Clostridioides Difficile Using Vancomycin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older treated as inpatients or outpatients at participating institutions
- Had an episode of CDI within the last 120 days confirmed by positive C. difficile tests and clinical symptoms
- Received treatment for the CDI episode with vancomycin or fidaxomicin for at least 10 days with clinical cure achieved
- Have received at least 3 days of oral or intravenous systemic antibiotics for a confirmed or suspected bacterial infection with at least one more day planned
You will not qualify if you...
- Treated the qualifying CDI episode with metronidazole alone or intravenous immunoglobulins
- Planned or received fecal microbiota transplantation, bezlotoxumab, VOWST, or REBYOTA for the CDI episode
- Unable to take medications orally or by nasogastric tube
- Have had a total colectomy
- Severe intolerance or allergy to oral vancomycin
- Did not achieve clinical cure during CDI treatment
- Ongoing or less than 1 day since finishing CDI treatment or CDI-active antibiotics
- Antibiotic use is only for prophylaxis or expected to last longer than 4 weeks
- Continuous systemic antibiotic use since CDI treatment without interruption
- Currently in palliative care or expected to die within 3 months from another illness
- Using non-systemic antibiotics or antibiotics not considered significant risk for CDI
- Previously enrolled in this trial
- Unable to consent without a healthcare proxy
- Lack health insurance
- Expected transfer to a non-participating site or palliative care
- Unable to participate in follow-up or lack contact means in outpatient setting
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
McGill University Health Centre
Montreal, Quebec, Canada, H4A3J1
Actively Recruiting
Research Team
E
Emily G. McDonald, MD MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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