Elaboration of consensus clinical endpoints to evaluate antimicrobial treatment efficacy in future HABP/VABP clinical trials.

Détails

ID Serval
serval:BIB_F0650CF235A2
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Elaboration of consensus clinical endpoints to evaluate antimicrobial treatment efficacy in future HABP/VABP clinical trials.
Périodique
Clinical infectious diseases
Auteur(s)
Weiss E., Zahar J.R., Alder J., Asehnoune K., Bassetti M., Bonten MJM, Chastre J., De Waele J., Dimopoulos G., Eggimann P., Engelhardt M., Ewig S., Kollef M., Lipman J., Luna C., Martin-Loeches I., Pagani L., Palmer L.B., Papazian L., Poulakou G., Prokocimer P., Rello J., Rex J.H., Shorr A.F., Talbot G.H., Thamlikitkul V., Torres A., Wunderink R.G., Timsit J.F.
ISSN
1537-6591 (Electronic)
ISSN-L
1058-4838
Statut éditorial
In Press
Peer-reviewed
Oui
Langue
anglais
Notes
Publication types: Journal Article
Publication Status: aheadofprint
Résumé
Randomized Clinical Trials (RCTs) in Hospital-Acquired (HABP) and Ventilator-Associated Bacterial Pneumonia (VABP) 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.
Twenty-six international experts from intensive care, infectious diseases and the pharmaceutical industry were polled using the Delphi method.
The panel recommended a hierarchical composite endpoint including, by priority order, for VABP (i) survival at day 28, (ii) mechanical ventilation (MV)-free-days through day 28, and (iii) clinical cure between study days 7 and 10; and for HABP (i) survival (day 28), and (ii) clinical cure (days 7-10). Clinical cure was defined as the combination of resolution of signs and symptoms present at enrolment and improvement or lack of progression of radiological signs. More than 70% of the experts agreed to assess survival and MV-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).
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.
Pubmed
Création de la notice
18/03/2019 19:06
Dernière modification de la notice
21/08/2019 5:36
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