@article{e9ee8507320846cda093e61673f245d0,
title = "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",
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.",
keywords = "BioVU, C. difficile, Clostridioides difficile, Misoprostol, PheWAS, Trial design",
author = "Lavieri, {Robert R.} and Dubberke, {Erik R.} and McGill, {Sarah K.} and Luther Bartelt and Smith, {Stephanie A.} and Pandur, {Balint K.} and Phillips, {Sharon E.} and Krista Vermillion and Jana Shirey-Rice and Jill Pulley and Yaomin Xu and Lindsell, {Christopher J.} and Nicole Zaleski and Rebecca Jerome and Doster, {Ryan S.} and Aronoff, {David M.}",
note = "Publisher Copyright: {\textcopyright} 2023 Elsevier Ltd",
year = "2023",
month = apr,
doi = "10.1016/j.anaerobe.2023.102699",
language = "English",
volume = "80",
journal = "Anaerobe",
issn = "1075-9964",
}