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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.
Lavieri, Robert R; Dubberke, Erik R; McGill, Sarah K; Bartelt, Luther; Smith, Stephanie A; Pandur, Balint K; Phillips, Sharon E; Vermillion, Krista; Shirey-Rice, Jana; Pulley, Jill; Xu, Yaomin; Lindsell, Christopher J; Zaleski, Nicole; Jerome, Rebecca; Doster, Ryan S; Aronoff, David M.
Afiliação
  • Lavieri RR; The Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, TN, USA.
  • Dubberke ER; Department of Medicine, Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.
  • McGill SK; Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.
  • Bartelt L; Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.
  • Smith SA; The Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, TN, USA.
  • Pandur BK; The Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, TN, USA.
  • Phillips SE; Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
  • Vermillion K; The Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, TN, USA.
  • Shirey-Rice J; The Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, TN, USA.
  • Pulley J; The Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, TN, USA.
  • Xu Y; Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
  • Lindsell CJ; The 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.
  • Zaleski N; The Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, TN, USA.
  • Jerome R; The Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, TN, USA.
  • Doster RS; Department of Medicine, University of Louisville School of Medicine, Louisville, KY, USA.
  • Aronoff DM; Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA. Electronic address: aronoff@iu.edu.
Anaerobe ; 80: 102699, 2023 Apr.
Article em En | MEDLINE | ID: mdl-36702174
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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Clostridioides difficile / Misoprostol / Infecções por Clostridium / COVID-19 Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Revista: Anaerobe Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Estados Unidos País de publicação: Reino Unido
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Clostridioides difficile / Misoprostol / Infecções por Clostridium / COVID-19 Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Revista: Anaerobe Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Estados Unidos País de publicação: Reino Unido