Telavancin hospital-acquired pneumonia trials: impact of Gram-negative infections and inadequate Gram-negative coverage on clinical efficacy and all-cause mortality.
Citation: Clinical Infectious Diseases. 61 Suppl 2:S87-93, 2015 Sep 15.PMID: 26316562Institution: MedStar Washington Hospital CenterDepartment: Medicine/Pulmonary-Critical CareForm of publication: Journal ArticleMedline article type(s): Clinical Trial, Phase III | Journal Article | Randomized Controlled Trial | Research Support, Non-U.S. Gov'tSubject headings: *Aminoglycosides/tu [Therapeutic Use] | *Anti-Bacterial Agents/tu [Therapeutic Use] | *Cross Infection/dt [Drug Therapy] | *Gram-Positive Bacterial Infections/dt [Drug Therapy] | *Pneumonia, Ventilator-Associated/dt [Drug Therapy] | *Pneumonia, Ventilator-Associated/th [Therapy] | Adult | Aminoglycosides/ad [Administration & Dosage] | Aminoglycosides/ae [Adverse Effects] | Anti-Bacterial Agents/ad [Administration & Dosage] | Anti-Bacterial Agents/ae [Adverse Effects] | Coinfection/dt [Drug Therapy] | Coinfection/mo [Mortality] | Cross Infection/mi [Microbiology] | Cross Infection/mo [Mortality] | Double-Blind Method | Female | Gram-Negative Bacterial Infections/dt [Drug Therapy] | Gram-Negative Bacterial Infections/mi [Microbiology] | Gram-Negative Bacterial Infections/mo [Mortality] | Gram-Positive Bacterial Infections/mi [Microbiology] | Gram-Positive Bacterial Infections/mo [Mortality] | Hospital Mortality | Humans | Male | Middle Aged | Pneumonia, Ventilator-Associated/mi [Microbiology] | Pneumonia, Ventilator-Associated/mo [Mortality] | Time Factors | Treatment Outcome | Vancomycin/tu [Therapeutic Use] | Young AdultYear: 2015Local holdings: Available online from MWHC library: June 1997 - present, Available in print through MWHC library: 1999 - Winter 2007ISSN:- 1058-4838
| Item type | Current library | Collection | Call number | Status | Date due | Barcode |
|---|---|---|---|---|---|---|
| Journal Article | MedStar Authors Catalog | Article | 26316562 | Available | 26316562 |
Available online from MWHC library: June 1997 - present, Available in print through MWHC library: 1999 - Winter 2007
BACKGROUND: When hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP) is caused by gram-positive and gram-negative pathogens or both (mixed infections), the adequacy of gram-negative coverage (GNC) can confound the assessment of a gram-positive agent under study. This analysis examines the influence of gram-negative infections and the adequacy of GNC on clinical efficacy and all-cause mortality in the telavancin HABP/VABP phase 3 ATTAIN trials (Assessment of Telavancin for Treatment of Hospital-Acquired Pneumonia).
METHODS: This post hoc analysis evaluated 3 patient groups from ATTAIN: (1) gram-positive-only infections, (2) gram-positive-only and mixed infections-adequate GNC, and (3) gram-negative-only infections and mixed infections with inadequate GNC. For each, clinical efficacy at test of cure and all-cause mortality at day 28 were compared for telavancin and vancomycin.
RESULTS/CONCLUSIONS: In the ATTAIN safety population there were 16 more deaths in the telavancin arms than in the vancomycin arms. Of these, 13 were in patients with gram-negative-only infections (n = 9) or with mixed infections and inadequate GNC (n = 4) and all had estimated baseline creatinine clearances of <30ml/min. Based on this analysis, clinical response and all-cause mortality could be confounded because there were more patients with gram-negative pathogens at baseline and more patients received inadequate treatment of these gram-negative infections in the telavancin groups.Copyright © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: [email protected].
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