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Elaboration of consensus clinical endpoints to evaluate antimicrobial treatment efficacy in future hospital-acquired/ventilator-associated bacterial pneumonia clinical trials

(2019) CLINICAL INFECTIOUS DISEASES. 69(11). p.1912-1918
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Abstract
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.
Keywords
hospital-acquired bacterial pneumonia, multinational consensus, Delphi method, hierarchical composite endpoint, clinical cure, VENTILATOR-ASSOCIATED PNEUMONIA, INFECTIONS, DURATION

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Citation

Please use this url to cite or link to this publication:

MLA
Weiss, Emmanuel, et al. “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, pp. 1912–18, doi:10.1093/cid/ciz093.
APA
Weiss, E., Zahar, J.-R., Alder, J., Asehnoune, K., Bassetti, M., Bonten, M. J., … Timsit, J.-F. (2019). Elaboration of consensus clinical endpoints to evaluate antimicrobial treatment efficacy in future hospital-acquired/ventilator-associated bacterial pneumonia clinical trials. CLINICAL INFECTIOUS DISEASES, 69(11), 1912–1918. https://doi.org/10.1093/cid/ciz093
Chicago author-date
Weiss, Emmanuel, Jean-Ralph Zahar, Jeff Alder, Karim Asehnoune, Matteo Bassetti, Marc JM Bonten, Jean Chastre, et al. 2019. “Elaboration of Consensus Clinical Endpoints to Evaluate Antimicrobial Treatment Efficacy in Future Hospital-Acquired/Ventilator-Associated Bacterial Pneumonia Clinical Trials.” CLINICAL INFECTIOUS DISEASES 69 (11): 1912–18. https://doi.org/10.1093/cid/ciz093.
Chicago author-date (all authors)
Weiss, Emmanuel, Jean-Ralph Zahar, Jeff Alder, Karim Asehnoune, Matteo Bassetti, Marc JM 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, and Jean-François Timsit. 2019. “Elaboration of Consensus Clinical Endpoints to Evaluate Antimicrobial Treatment Efficacy in Future Hospital-Acquired/Ventilator-Associated Bacterial Pneumonia Clinical Trials.” CLINICAL INFECTIOUS DISEASES 69 (11): 1912–1918. doi:10.1093/cid/ciz093.
Vancouver
1.
Weiss E, Zahar J-R, Alder J, Asehnoune K, Bassetti M, Bonten MJ, et al. Elaboration of consensus clinical endpoints to evaluate antimicrobial treatment efficacy in future hospital-acquired/ventilator-associated bacterial pneumonia clinical trials. CLINICAL INFECTIOUS DISEASES. 2019;69(11):1912–8.
IEEE
[1]
E. Weiss et al., “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, pp. 1912–1918, 2019.
@article{8599598,
  abstract     = {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.},
  author       = {Weiss, Emmanuel and Zahar, Jean-Ralph and Alder, Jeff and Asehnoune, Karim and Bassetti, Matteo and Bonten, Marc JM and Chastre, Jean and De Waele, Jan and Dimopoulos, George and Eggimann, Philippe and Engelhardt, Marc and Ewig, Santiago and Kollef, Marin and Lipman, Jeffrey and Luna, Carlos and Martin-Loeches, Ignacio and Pagani, Leonardo and Palmer, Lucy B and Papazian, Laurent and Poulakou, Garyphallia and Prokocimer, Philippe and Rello, Jordi and Rex, John H and Shorr, Andrew F and Talbot, George H and Thamlikitkul, Visanu and Torres, Antoni and Wunderink, Richard G and Timsit, Jean-François},
  issn         = {1058-4838},
  journal      = {CLINICAL INFECTIOUS DISEASES},
  keywords     = {hospital-acquired bacterial pneumonia,multinational consensus,Delphi method,hierarchical composite endpoint,clinical cure,VENTILATOR-ASSOCIATED PNEUMONIA,INFECTIONS,DURATION},
  language     = {eng},
  number       = {11},
  pages        = {1912--1918},
  title        = {Elaboration of consensus clinical endpoints to evaluate antimicrobial treatment efficacy in future hospital-acquired/ventilator-associated bacterial pneumonia clinical trials},
  url          = {http://dx.doi.org/10.1093/cid/ciz093},
  volume       = {69},
  year         = {2019},
}

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