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.

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