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

Elsevier

Available online 23 January 2023, 102699

AnaerobeAuthor links open overlay panelAbstract

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.

Section snippetsSource of funding

This research was primarily supported by the National Institutes of Health (NCATS 5U01TR002398-03). Additional support for the project was provided by Vanderbilt's CTSA award (5UL1TR002243-0). R.S.D. is supported by NIAID career development award (1K08AI151100).

Contribution of authors

Robert R. Lavieri: Conceptualization, Methodology, Writing – original draft, Project administration, Funding acquisition, Erik R. Dubberke: Conceptualization, Methodology, Investigation, Writing – review & editing, Funding acquisition, Sarah K. McGill: Conceptualization, Methodology, Investigation, Writing – review & editing, Funding acquisition, Luther Bartelt: Investigation, Stephanie A. Smith: Methodology, Project administration, Writing – review & editing, Balint K. Pandur: Writing –

Declaration of competing interest

S.K.M.: Research funding from Finch Therapeutics.

E.R.D: Research funding provided by Ferring, Synthetic Biologics, and Pfizer; Consultant for Summit, Seres, Abbott, Pfizer, Merck, Ferring.

Acknowledgment

The authors acknowledge all patients who volunteered their time to learn about the study and the 7 patients who volunteered to participate in the study, staff at all 3 study sites, the 3 members of the DSMB including Leslie J. Crofford, M.D., Dawn B. Beaulieu, MD, and Jody D. Ciolino, PhD., and current and previous NCATS program officials including Dr. Bobbie Ann Mount, Dr. Soju Chang, and Dr. Eugene Passamani.

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© 2023 Published by Elsevier Ltd.

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