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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.

Publication ,  Journal Article
Lavieri, RR; Dubberke, ER; McGill, SK; Bartelt, L; Smith, SA; Pandur, BK; Phillips, SE; Vermillion, K; Shirey-Rice, J; Pulley, J; Xu, Y ...
Published in: Anaerobe
April 2023

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.

Duke Scholars

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Published In

Anaerobe

DOI

EISSN

1095-8274

Publication Date

April 2023

Volume

80

Start / End Page

102699

Location

England

Related Subject Headings

  • Misoprostol
  • Microbiology
  • Humans
  • Feasibility Studies
  • Clostridium Infections
  • Clostridioides difficile
  • Clostridioides
  • COVID-19
  • 3202 Clinical sciences
  • 3107 Microbiology
 

Citation

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Lavieri, R. R., Dubberke, E. R., McGill, S. K., Bartelt, L., Smith, S. A., Pandur, B. K., … Aronoff, D. M. (2023). 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, 80, 102699. https://doi.org/10.1016/j.anaerobe.2023.102699
Lavieri, Robert R., Erik R. Dubberke, Sarah K. McGill, Luther Bartelt, Stephanie A. Smith, Balint K. Pandur, Sharon E. Phillips, 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 80 (April 2023): 102699. https://doi.org/10.1016/j.anaerobe.2023.102699.
Lavieri RR, Dubberke ER, McGill SK, Bartelt L, Smith SA, Pandur BK, Phillips SE, Vermillion K, Shirey-Rice J, Pulley J, Xu Y, Lindsell CJ, Zaleski N, Jerome R, Doster RS, Aronoff DM. 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.
Journal cover image

Published In

Anaerobe

DOI

EISSN

1095-8274

Publication Date

April 2023

Volume

80

Start / End Page

102699

Location

England

Related Subject Headings

  • Misoprostol
  • Microbiology
  • Humans
  • Feasibility Studies
  • Clostridium Infections
  • Clostridioides difficile
  • Clostridioides
  • COVID-19
  • 3202 Clinical sciences
  • 3107 Microbiology