Evidence map›Paper›PMID 36702174›Full record

Trial reportAnaerobe2023

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.

Robert R Lavieri, Erik R Dubberke, Sarah K McGill, Luther Bartelt, Stephanie A Smith, Balint K Pandur, Sharon E Phillips, Krista Vermillion, Jana Shirey-Rice, Jill Pulley and 6 more

Open access · greenAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Anaerobe, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.6field-weighted citation impact, top 37% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Pharmacological reduction of neutrophil infiltration reducesbioRxiv : the preprint server for biology · 2025
    Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 5 institutions in 1 country.

Robert R LavieriThe Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, TN, USA.
Erik R DubberkeDepartment of Medicine, Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.
Sarah K McGillDepartment of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.
Luther BarteltDepartment of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.
Stephanie A SmithThe Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, TN, USA.
Balint K PandurThe Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, TN, USA.
Sharon E PhillipsDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
Krista VermillionThe Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, TN, USA.
Jana Shirey-RiceThe Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, TN, USA.
Jill PulleyThe Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, TN, USA.
Yaomin XuDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
Christopher J LindsellThe Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, TN, USA; Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
Nicole ZaleskiThe Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, TN, USA.
Rebecca JeromeThe Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, TN, USA.
Ryan S DosterDepartment of Medicine, University of Louisville School of Medicine, Louisville, KY, USA.
David M AronoffDepartment of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA. Electronic address: aronoff@iu.edu.
Vanderbilt University Medical Center · USUniversity of North Carolina at Chapel Hill · USIndiana University School of MedicineUniversity of Louisville · USWashington University in St. Louis · US

Funding

Vanderbilt Institute for Clinical and Translational Research (VICTR) -Identifying correlates of functional immunity in SARS-CoV-2 convalescent plasmaUL1TR002243 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Paul A. Harris, Wesley H Self · 2017 to 2026
$130.7M
Repurposing misoprostol to prevent recurrence of Clostridium difficile infectionU01TR002398 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI DOSTER, RYAN S, DUBBERKE, ERIK R · 2018 to 2019
$3.1M
Defining the impact of zinc on Streptococcus agalactiae biofilm and colonizationK08AI151100 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI DOSTER, RYAN S · 2020 to 2024
$927k
NCATS NIH HHS U01 TR002398NCATS NIH HHS UL1 TR002243NIAID NIH HHS K08 AI151100
6 · The paper itself

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.

Indexed as

Clostridioides difficileClostridium InfectionsCOVID-19MisoprostolClostridioidesFeasibility StudiesHumansMisoprostolBioVUC. difficileClostridioides difficileMisoprostolPheWASTrial design

Identifiers

PMID36702174
PMCPMC10793995
OpenAlexW4317725603

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.