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DC Field | Value | Language |
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dc.contributor.author | Torres Martí, Antoni | - |
dc.contributor.author | Rank, Doug | - |
dc.contributor.author | Melnick, David | - |
dc.contributor.author | Rekeda, Ludmyla | - |
dc.contributor.author | Chen, Xiang | - |
dc.contributor.author | Riccobene, Todd | - |
dc.contributor.author | Critchley, Ian A. | - |
dc.contributor.author | Lakkis, Hassan D. | - |
dc.contributor.author | Taylor, Dianna | - |
dc.contributor.author | Talley, Angela K. | - |
dc.date.accessioned | 2020-05-27T15:44:34Z | - |
dc.date.available | 2020-05-27T15:44:34Z | - |
dc.date.issued | 2019-04-25 | - |
dc.identifier.issn | 2328-8957 | - |
dc.identifier.uri | http://hdl.handle.net/2445/162663 | - |
dc.description.abstract | Background: Hospital-acquired and ventilator-associated pneumonia (HAP/VAP; nosocomial pneumonia) due to Gram-negative pathogens are associated with significant morbidity and mortality; treatment options for multidrug-resistant infections are limited. The pivotal phase III REPROVE trial evaluated the efficacy of ceftazidime-avibactam (CAZ-AVI) vs meropenem in the treatment of patients with HAP/VAP. Study results for prespecified analyses per US Food and Drug Administration-recommended trial end points are reported here. Methods: Hospitalized adults with HAP/VAP proven or suspected to be caused by a Gram-negative pathogen were randomized 1:1 to receive CAZ-AVI or meropenem for 7 to 14 days. The primary outcome was 28-day all-cause mortality in the intent-to-treat (ITT) population. Secondary outcomes included clinical cure at test of cure (TOC) in the ITT and microbiological ITT (micro-ITT) populations, and safety and tolerability throughout the study. Results: hundred seventy randomized patients received treatment and were included in the ITT population (CAZ-AVI, n = 436; meropenem, n = 434). CAZ-AVI was noninferior to meropenem for the primary end point (28-day all-cause mortality; ITT) based on the prespecified 10% noninferiority margin (CAZ-AVI, 9.6%; meropenem, 8.3%; difference, 1.5%; 95% confidence interval [CI], -2.4% to 5.3%) and for the clinical cure end point in the ITT population based on a prespecified -10% noninferiority margin (CAZ-AVI, 67.2%; meropenem, 69.1%; difference, −1.9%; 95% CI, -8.1% to 4.3%). Clinical cure rates at TOC for patients infected with CAZ-nonsusceptible pathogens were similar (CAZ-AVI, 75.5%; meropenem, 71.2%; micro-ITT). Safety data were consistent with established safety profiles for both agents. Conclusions: CAZ-AVI provides an important new treatment option for HAP/VAP due to Gram-negative pathogens, including CAZ-nonsusceptible strains. | - |
dc.format.extent | 11 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Oxford University Press | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1093/ofid/ofz149 | - |
dc.relation.ispartof | Open Forum Infectious Diseases, 2019, vol. 6, num. 4, p. 149 | - |
dc.relation.uri | https://doi.org/10.1093/ofid/ofz149 | - |
dc.rights | cc-by-nc-nd (c) Torres Martí, Antoni et al., 2019 | - |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/3.0/es | - |
dc.source | Articles publicats en revistes (Medicina) | - |
dc.subject.classification | Pneumònia adquirida a la comunitat | - |
dc.subject.classification | Microorganismes patògens | - |
dc.subject.classification | Farmacologia | - |
dc.subject.other | Community-acquired pneumonia | - |
dc.subject.other | Pathogenic microorganisms | - |
dc.subject.other | Pharmacology | - |
dc.title | Randomized Trial of Ceftazidime-Avibactam vs Meropenem for Treatment of Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (REPROVE): Analyses per US FDA-Specified End Points | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.identifier.idgrec | 698269 | - |
dc.date.updated | 2020-05-27T15:44:35Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 31041348 | - |
Appears in Collections: | Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer) Articles publicats en revistes (Medicina) |
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