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Title: Elaboration of Consensus Clinical Endpoints to Evaluate Antimicrobial Treatment Efficacy in Future Hospital-acquired/Ventilator-associated Bacterial Pneumonia Clinical Trials
Authors: Emmanuel Weiss
Jean Ralph Zahar
Jeff Alder
Karim Asehnoune
Matteo Bassetti
Marc J.M. Bonten
Jean Chastre
Jan De Waele
George Dimopoulos
Philippe Eggimann
Marc Engelhardt
Santiago Ewig
Marin Kollef
Jeffrey Lipman
Carlos Luna
Ignacio Martin-Loeches
Leonardo Pagani
Lucy B. Palmer
Laurent Papazian
Garyphallia Poulakou
Philippe Prokocimer
Jordi Rello
John H. Rex
Andrew F. Shorr
George H. Talbot
Visanu Thamlikitkul
Antoni Torres
Richard G. Wunderink
Jean François Timsit
F2G Limited
Centro de Investigación Biomédica en Red de Enfermedades Respiratorias
Regional Hospital of Bolzano
Augusta Krankenanstalt
University Hospital of Ghent
University of Athens Medical School
University Medical Center Utrecht
Royal Brisbane and Women's Hospital
Washington Hospital Center
Sotiria General Hospital
Stony Brook University
Università degli Studi di Udine
Basilea Pharmaceutica Ltd.
Hôtel Dieu CHU de Nantes
Centre Hospitalier Universitaire Vaudois
Hôpital Bichat-Claude-Bernard AP-HP
Washington University School of Medicine in St. Louis
University of Witwatersrand
Hôpital Universitaire Pitié Salpêtrière
Attikon University Hospital
Northwestern University Feinberg School of Medicine
Hôpital Nord AP-HM
Faculty of Medicine, Siriraj Hospital, Mahidol University
Trinity College Dublin
Universite Paris 13
Hospital de Clinicas Jose de San Martin
Hopital Avicenne
Merck & Co., Inc.
Hopital Beaujon
Universite Paris 7- Denis Diderot
Universitat de Barcelona
Bayer US LLC
Talbot Advisors LLC
Keywords: Medicine
Issue Date: 13-Nov-2019
Citation: Clinical Infectious Diseases. Vol.69, No.11 (2019), 1912-1918
Abstract: © 2019 The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: Background: Randomized clinical trials (RCTs) in hospital-acquired and ventilator-associated bacterial pneumonia (HABP and VABP, respectively) are important for the evaluation of new antimicrobials. However, the heterogeneity in endpoints used in RCTs evaluating treatment of HABP/VABP may puzzle clinicians. The aim of this work was to reach a consensus on clinical endpoints to consider in future clinical trials evaluating antimicrobial treatment efficacy for HABP/VABP. Methods: Twenty-six international experts from intensive care, infectious diseases, and the pharmaceutical industry were polled using the Delphi method. Results: The panel recommended a hierarchical composite endpoint including, by priority order, (1) survival at day 28, (2) mechanical ventilation-free days through day 28, and (3) clinical cure between study days 7 and 10 for VABP; and (1) survival (day 28) and (2) clinical cure (days 7-10) for HABP. Clinical cure was defined as the combination of resolution of signs and symptoms present at enrollment and improvement or lack of progression of radiological signs. More than 70% of the experts agreed to assess survival and mechanical ventilation-free days though day 28, and clinical cure between day 7 and day 10 after treatment initiation. Finally, the hierarchical order of endpoint components was reached after 3 Delphi rounds (72% agreement). Conclusions: We provide a multinational expert consensus on separate hierarchical composite endpoints for VABP and HABP, and on a definition of clinical cure that could be considered for use in future HABP/VABP clinical trials.
ISSN: 15376591
Appears in Collections:Scopus 2019

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