Walk before you run: feasibility challenges and lessons learned from the PROCLAIM Study, a multicenter randomized controlled trial of misoprostol for prevention of recurrent C. difficile during COVID-19
Date
2023
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American English
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Abstract
We analyzed our challenging experience with a randomized controlled trial of misoprostol for prevention of recurrent C. difficile. Despite careful prescreening and thoughtful protocol modifications to facilitate enrollment, we closed the study early after enrolling just 7 participants over 3 years. We share lessons learned, noting the importance of feasibility studies, inclusion of biomarker outcomes, and dissemination of such findings to inform future research design and implementation successes.
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Lavieri RR, Dubberke ER, McGill SK, et al. Walk before you run: Feasibility challenges and lessons learned from the PROCLAIM study, a multicenter randomized controlled trial of misoprostol for prevention of recurrent Clostridioides difficile during COVID-19. Anaerobe. 2023;80:102699. doi:10.1016/j.anaerobe.2023.102699
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