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

MedStar author(s):
Citation: Clinical Infectious Diseases. 69(11):1912-1918, 2019 11 13.PMID: 30722013Institution: MedStar Washington Hospital CenterDepartment: Medicine/Pulmonary-Critical CareForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Anti-Bacterial Agents/tu [Therapeutic Use] | *Pneumonia, Bacterial/mi [Microbiology] | *Pneumonia, Ventilator-Associated/dt [Drug Therapy] | Consensus | Critical Care/mt [Methods] | Cross Infection/dt [Drug Therapy] | Cross Infection/mi [Microbiology] | Humans | Pneumonia, Bacterial/dt [Drug Therapy] | Pneumonia, Ventilator-Associated/mi [Microbiology] | Treatment OutcomeYear: 2019Local holdings: Available online from MWHC library: June 1997 - present, Available in print through MWHC library: 1999 - Winter 2007ISSN:
  • 1058-4838
Name of journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of AmericaAbstract: Background: 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.Conclusion: 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.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, 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).All authors: 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 LB, Papazian L, Poulakou G, Prokocimer P, Rello J, Rex JH, Shorr AF, Talbot GH, Thamlikitkul V, Timsit JF, Torres A, Weiss E, Wunderink RG, Zahar JROriginally published: Clinical Infectious Diseases. 2019 Feb 04Fiscal year: FY2020Fiscal year of original publication: FY2019Digital Object Identifier: Date added to catalog: 2019-03-14
Holdings
Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 30722013 Available 30722013

Available online from MWHC library: June 1997 - present, Available in print through MWHC library: 1999 - Winter 2007

Background: 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.

Conclusion: 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.

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, 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).

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