Emmanuel WeissJean Ralph ZaharJeff AlderKarim AsehnouneMatteo BassettiMarc J.M. BontenJean ChastreJan De WaeleGeorge DimopoulosPhilippe EggimannMarc EngelhardtSantiago EwigMarin KollefJeffrey LipmanCarlos LunaIgnacio Martin-LoechesLeonardo PaganiLucy B. PalmerLaurent PapazianGaryphallia PoulakouPhilippe ProkocimerJordi RelloJohn H. RexAndrew F. ShorrGeorge H. TalbotVisanu ThamlikitkulAntoni TorresRichard G. WunderinkJean François TimsitF2G LimitedCentro de Investigación Biomédica en Red de Enfermedades RespiratoriasRegional Hospital of BolzanoAugusta KrankenanstaltUniversity Hospital of GhentUniversity of Athens Medical SchoolUniversity Medical Center UtrechtRoyal Brisbane and Women's HospitalWashington Hospital CenterSotiria General HospitalStony Brook UniversityUniversità degli Studi di UdineBasilea Pharmaceutica Ltd.Hôtel Dieu CHU de NantesCentre Hospitalier Universitaire VaudoisHôpital Bichat-Claude-Bernard AP-HPWashington University School of Medicine in St. LouisUniversity of WitwatersrandHôpital Universitaire Pitié SalpêtrièreAttikon University HospitalNorthwestern University Feinberg School of MedicineHôpital Nord AP-HMFaculty of Medicine, Siriraj Hospital, Mahidol UniversityTrinity College DublinUniversite Paris 13Hospital de Clinicas Jose de San MartinHopital AvicenneMerck & Co., Inc.Hopital BeaujonUniversite Paris 7- Denis DiderotUniversitat de BarcelonaInsermBayer US LLCTalbot Advisors LLC2020-01-272020-01-272019-11-13Clinical Infectious Diseases. Vol.69, No.11 (2019), 1912-191815376591105848382-s2.0-85074958165https://repository.li.mahidol.ac.th/handle/20.500.14594/51311© 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.Mahidol UniversityMedicineArticleSCOPUS10.1093/cid/ciz093