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

Robert R Lavieri; Erik R Dubberke; Sarah K McGill; Luther Bartelt; Stephanie A Smith; Balint K Pandur; Sharon E Phillips; Krista Vermillion; Jana Shirey-Rice; Jill Pulley; Yaomin Xu; Christopher J Lindsell; Nicole Zaleski; Rebecca Jerome; Ryan S Doster; David M Aronoff

doi:10.1016/j.anaerobe.2023.102699

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 Apr:80:102699. doi: 10.1016/j.anaerobe.2023.102699. Epub 2023 Jan 23.

Authors

Robert R Lavieri¹, Erik R Dubberke², Sarah K McGill³, Luther Bartelt³, Stephanie A Smith¹, Balint K Pandur¹, Sharon E Phillips⁴, Krista Vermillion¹, Jana Shirey-Rice¹, Jill Pulley¹, Yaomin Xu⁴, Christopher J Lindsell⁵, Nicole Zaleski¹, Rebecca Jerome¹, Ryan S Doster⁶, David M Aronoff⁷

Affiliations

¹ The Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, TN, USA.
² Department of Medicine, Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.
³ Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.
⁴ Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
⁵ The Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, TN, USA; Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
⁶ Department of Medicine, University of Louisville School of Medicine, Louisville, KY, USA.
⁷ Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA. Electronic address: aronoff@iu.edu.

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.

Publication types

Randomized Controlled Trial
Multicenter Study

MeSH terms

COVID-19* / prevention & control
Clostridioides
Clostridioides difficile*
Clostridium Infections* / prevention & control
Feasibility Studies
Humans
Misoprostol* / therapeutic use

Substances

Misoprostol

Abstract

Publication types

MeSH terms

Substances

Grants and funding