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
| dc.contributor.author | Lavieri, Robert R. | |
| dc.contributor.author | Dubberke, Erik R. | |
| dc.contributor.author | McGill, Sarah K. | |
| dc.contributor.author | Bartelt, Luther | |
| dc.contributor.author | Smith, Stephanie A. | |
| dc.contributor.author | Pandur, Balint K. | |
| dc.contributor.author | Phillips, Sharon E. | |
| dc.contributor.author | Vermillion, Krista | |
| dc.contributor.author | Shirey-Rice, Jana | |
| dc.contributor.author | Pulley, Jill | |
| dc.contributor.author | Xu, Yaomin | |
| dc.contributor.author | Lindsell, Christopher J. | |
| dc.contributor.author | Zaleski, Nicole | |
| dc.contributor.author | Jerome, Rebecca | |
| dc.contributor.author | Doster, Ryan S. | |
| dc.contributor.author | Aronoff, David M. | |
| dc.contributor.department | Medicine, School of Medicine | |
| dc.date.accessioned | 2024-07-11T12:06:28Z | |
| dc.date.available | 2024-07-11T12:06:28Z | |
| dc.date.issued | 2023 | |
| dc.description.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. | |
| dc.eprint.version | Author's manuscript | |
| dc.identifier.citation | 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 | |
| dc.identifier.uri | https://hdl.handle.net/1805/42114 | |
| dc.language.iso | en_US | |
| dc.publisher | Elsevier | |
| dc.relation.isversionof | 10.1016/j.anaerobe.2023.102699 | |
| dc.relation.journal | Anaerobe | |
| dc.rights | Publisher Policy | |
| dc.source | PMC | |
| dc.subject | BioVU | |
| dc.subject | C. difficile | |
| dc.subject | Clostridioides difficile | |
| dc.subject | Misoprostol | |
| dc.subject | PheWAS | |
| dc.subject | Trial design | |
| dc.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 | |
| dc.type | Article |