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
APA
Chicago
ICMJE
MLA
NLM
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, 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 Apr;80:102699.
Lavieri, Robert R., 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, vol. 80, Apr. 2023, p. 102699. Pubmed, doi: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.
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