Analysis of the impact of secondary prophylaxis on Clostridioides difficile recurrence in critically ill adults.
Kathryn A Connor, Kelly M Conn
https://pubmed.ncbi.nlm.nih.gov/32587690/Actively Recruiting
Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2026-06-24
300
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are evaluating whether oral vancomycin can prevent recurrent Clostridioides difficile infections CDI in adults who recently had CDI and are exposed again to systemic antibiotics. This is a randomized, double-blind trial comparing vancomycin prophylaxis to placebo. CDI causes severe diarrhea and has a high rate of recurrence, leading to significant health risks and economic costs. Antibiotic re-exposure is a major risk factor for recurrence, and this study aims to determine if vancomycin given during antibiotic use reduces that risk. Participants will take either oral vancomycin or placebo capsules twice daily during the course of systemic antibiotic treatment and then once daily for seven days after finishing antibiotics. The trial includes two groups one receiving vancomycin 125mg and the other receiving placebo capsules matching the dosing schedule. The study drug is taken orally, and the treatment period matches the duration of antibiotic use plus an additional week. During the study, participants will attend a follow-up visit in person or by phone at day 56 and complete weekly electronic questionnaires. Researchers will monitor CDI recurrence up to 56 days as the primary outcome and also track late recurrence, mortality, emergency visits, hospital admissions, adverse events, and drug discontinuation. The study aims to provide clear evidence on vancomycins role in preventing recurrent CDI during antibiotic re-exposure, with participation expected to last several months.
CONDITIONS
Secondary Prevention of Clostridioides Difficile Using Vancomycin
E
Emily G. McDonald, MD MSc
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McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of systemic antibiotic use plus 7 days
Participants take oral vancomycin or placebo capsules twice daily during systemic antibiotic treatment and once daily for 7 days after antibiotics finish.
Duration - Up to 56 days after treatment
Participants complete weekly electronic questionnaires and attend an in-person or phone follow-up visit on day 56 to assess outcomes including CDI recurrence and safety.
1 visit (in-person or phone) and weekly questionnaires
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Lead Sponsor