Publication:
Elaboration of Consensus Clinical Endpoints to Evaluate Antimicrobial Treatment Efficacy in Future Hospital-acquired/Ventilator-associated Bacterial Pneumonia Clinical Trials

Issued Date

2019-11-13

Resource Type

Article

ISSN

15376591
10584838

DOI

10.1093/cid/ciz093

Other identifier(s)

2-s2.0-85074958165

Rights

Mahidol University

Rights Holder(s)

SCOPUS

Bibliographic Citation

Clinical Infectious Diseases. Vol.69, No.11 (2019), 1912-1918

Suggested Citation

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 Elaboration of Consensus Clinical Endpoints to Evaluate Antimicrobial Treatment Efficacy in Future Hospital-acquired/Ventilator-associated Bacterial Pneumonia Clinical Trials. Clinical Infectious Diseases. Vol.69, No.11 (2019), 1912-1918. doi:10.1093/cid/ciz093 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/51311

Research Projects

Organizational Units

Authors

Journal Issue

Thesis

Title

Elaboration of Consensus Clinical Endpoints to Evaluate Antimicrobial Treatment Efficacy in Future Hospital-acquired/Ventilator-associated Bacterial Pneumonia Clinical Trials

Author(s)

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

Other Contributor(s)

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
 Inserm
 Bayer US LLC
 Talbot Advisors LLC

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: journals.permissions@oup.com. 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.

Keyword(s)

Medicine

Availability

URI

https://repository.li.mahidol.ac.th/handle/20.500.14594/51311

Collections

Scopus 2019