Walk before you run: Feasibility challenges and lessons learned from the PROCLAIM study, a multicenter randomized controlled trial of misoprostol for prevention of recurrent C. difficile during COVID-19
AUTHORS
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 ,
. Anaerobe. 2023 1 23; 80(). 102699
- PMID: 36702174 [PubMed].
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.
Tags: 2023 Alumni Publications