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.
BioVU
C. difficile
Clostridioides difficile
Misoprostol
PheWAS
Trial design
Journal
Anaerobe
ISSN: 1095-8274
Titre abrégé: Anaerobe
Pays: England
ID NLM: 9505216
Informations de publication
Date de publication:
Apr 2023
Apr 2023
Historique:
received:
04
12
2022
revised:
09
01
2023
accepted:
20
01
2023
medline:
25
4
2023
pubmed:
27
1
2023
entrez:
26
1
2023
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 36702174
pii: S1075-9964(23)00008-2
doi: 10.1016/j.anaerobe.2023.102699
pii:
doi:
Substances chimiques
Misoprostol
0E43V0BB57
Types de publication
Randomized Controlled Trial
Multicenter Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
102699Subventions
Organisme : NCATS NIH HHS
ID : U01 TR002398
Pays : United States
Informations de copyright
Copyright © 2023 Elsevier Ltd. All rights reserved.
Déclaration de conflit d'intérêts
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.