Elaboration of Consensus Clinical Endpoints to Evaluate Antimicrobial Treatment Efficacy in Future Hospital-acquired/Ventilator-associated Bacterial Pneumonia Clinical Trials. (Record no. 4100)

MARC details
000 -LEADER
fixed length control field 03923nam a22005417a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 190314s20192019 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 1058-4838
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code 10.1093/cid/ciz093 [doi]
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code 5306480 [pii]
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 30722013
245 ## - TITLE STATEMENT
Title Elaboration of Consensus Clinical Endpoints to Evaluate Antimicrobial Treatment Efficacy in Future Hospital-acquired/Ventilator-associated Bacterial Pneumonia Clinical Trials.
251 ## - Source
Source Clinical Infectious Diseases. 69(11):1912-1918, 2019 11 13.
252 ## - Abbreviated Source
Abbreviated source Clin Infect Dis. 69(11):1912-1918, 2019 11 13.
252 ## - Abbreviated Source
Former abbreviated source Clin Infect Dis. 2019 Feb 04
253 ## - Journal Name
Journal name Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2019
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2020
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Publication status aheadofprint
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Publication status ppublish
266 ## - Date added to catalog
Date added to catalog 2019-03-14
268 ## - Previous citation
-- Clinical Infectious Diseases. 2019 Feb 04
269 ## - Original dates
Original fiscal year FY2019
501 ## - WITH NOTE
Local holdings Available online from MWHC library: June 1997 - present, Available in print through MWHC library: 1999 - Winter 2007
520 ## - SUMMARY, ETC.
Abstract 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.
520 ## - SUMMARY, ETC.
Abstract 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.
520 ## - SUMMARY, ETC.
Abstract Methods: Twenty-six international experts from intensive care, infectious diseases and the pharmaceutical industry were polled using the Delphi method.
520 ## - SUMMARY, ETC.
Abstract 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).
546 ## - LANGUAGE NOTE
Language note English
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Anti-Bacterial Agents/tu [Therapeutic Use]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Pneumonia, Bacterial/mi [Microbiology]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Pneumonia, Ventilator-Associated/dt [Drug Therapy]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Consensus
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Critical Care/mt [Methods]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Cross Infection/dt [Drug Therapy]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Cross Infection/mi [Microbiology]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Humans
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Pneumonia, Bacterial/dt [Drug Therapy]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Pneumonia, Ventilator-Associated/mi [Microbiology]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Treatment Outcome
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution MedStar Washington Hospital Center
656 ## - INDEX TERM--OCCUPATION
Department Medicine/Pulmonary-Critical Care
657 ## - INDEX TERM--FUNCTION
Medline publication type Journal Article
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Shorr, Andrew F
790 ## - Authors
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 JR
856 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="https://dx.doi.org/10.1093/cid/ciz093">https://dx.doi.org/10.1093/cid/ciz093</a>
Public note https://dx.doi.org/10.1093/cid/ciz093
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
Holdings
Withdrawn status Lost status Damaged status Not for loan Collection Home library Current library Date acquired Total Checkouts Full call number Barcode Date last seen Price effective from Koha item type
          MedStar Authors Catalog MedStar Authors Catalog 03/14/2019   30722013 30722013 03/14/2019 03/14/2019 Journal Article

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