Elaboration of Consensus Clinical Endpoints to Evaluate Antimicrobial Treatment Efficacy in Future Hospital-acquired/Ventilator-associated Bacterial Pneumonia Clinical Trials
- Creators
- Weiss E.
- Zahar J. -R.
- Alder J.
- Asehnoune K.
- Bassetti M.
- Bonten M. J. M.
- 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.
- Others:
- Weiss, E.
- Zahar, J. -R.
- Alder, J.
- Asehnoune, K.
- Bassetti, M.
- Bonten, M. J. M.
- 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.
Description
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.
Additional details
- URL
- http://hdl.handle.net/11567/993006
- URN
- urn:oai:iris.unige.it:11567/993006
- Origin repository
- UNIGE