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dc.creatorRosso Fernández, Claraes
dc.creatorGarnacho Montero, Josées
dc.creatorAntonelli, M.es
dc.creatorDimopoulos, Georgees
dc.creatorCisneros Herreros, José Migueles
dc.creatorMagicBullet Working Group WP4es
dc.creatorPulido, Marina R.es
dc.date.accessioned2024-03-15T10:47:02Z
dc.date.available2024-03-15T10:47:02Z
dc.date.issued2015
dc.identifier.citationRosso Fernández, C., Garnacho Montero, J., Antonelli, M., Dimopoulos, G., Cisneros Herreros, J.M., MagicBullet Working Group WP4, y Pulido, M.R. (2015). Safety and efficacy of colistin versus meropenem in the empirical treatment of ventilator-associated pneumonia as part of a macro-project funded by the Seventh Framework Program of the European Commission studying off-patent antibiotics: study protocol for a randomized controlled trial. Trials, 16 (1), 1-11. https://doi.org/10.1186/s13063-015-0614-4.
dc.identifier.issn1745-6215es
dc.identifier.urihttps://hdl.handle.net/11441/156314
dc.description.abstractBackground Ventilator-associated pneumonia (VAP) is one of the most common and severe hospital-adquired infections, and multidrugresistant gram-negative bacilli (MDR-GNB) constitute the main etiology in many countries. Inappropriate empiric antimicrobial treatment is associated with increased mortality. In this context, the empirical treatment of choice for VAP is unknown. Colistin, is now the antimicrobial with greatest in vitro activity against MDR-GNB. Methods/Design The MagicBullet clinical trial is an investigator-driven clinical study, funded by the Seventh Framework Program of the European Commission. This is designed as a phase IV, randomized, controlled, open label, non-inferiority and international trial to assess the safety and efficacy of colistin versus meropenem in late onset VAP. The study is conducted in a total of 32 centers in three European countries (Spain, Italy and Greece) with specific high incidences of infections caused by MDR-GNB. Patients older than 18 years who develop VAP with both clinical and radiological signs, and are on mechanical ventilation for more than 96 hours, or less than 96 hours but with previous antibiotic treatment plus one week of hospitalization, are candidates for inclusion in the study. A total sample size of 496 patients will be randomized according to a severity clinical score (at the time of VAP diagnosis in a 1:1 ratio to receive either colistin 4.5 MU as a loading dose, followed by 3 MU every eight hours (experimental arm), or meropenem 2 g every eight hours (control arm), both combined with levofloxacin. Mortality from any cause at 28 days will be considered as the main outcome. Clinical and microbiological cure will be evaluated at 72 hours, eight days, the finalization of antibiotic treatment, and 28 days of follow-up. The efficacy evaluation will be performed in every patient who receives at least one study treatment drug, and with etiologic diagnosis of VAP, intention-to-treat population and per protocol analysis will be performed. Discussion Currently, there is no study being undertaken which analyzes empiric treatment of (VAP) with a suspicion of multi-resistance. Colistin, an off-patent antibiotic commercialized for more than 60 years, could widen the antibiotic alternatives for a high-mortality illness aggravated by antibiotic resistance.es
dc.description.sponsorshipEuropean Union Directorate General for Research and Innovation under the Health Cooperation Work Programme of the Seventh Framework 278232es
dc.formatapplication/pdfes
dc.format.extent11es
dc.language.isoenges
dc.publisherBMCes
dc.relation.ispartofTrials, 16 (1), 1-11.
dc.rightsAtribución 4.0 Internacional*
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/*
dc.subjectInvestigator-drivenes
dc.subjectRandomized controlled triales
dc.subjectOff-label antibiotics resistancees
dc.subjectMultidrug-resistantes
dc.titleSafety and efficacy of colistin versus meropenem in the empirical treatment of ventilator-associated pneumonia as part of a macro-project funded by the Seventh Framework Program of the European Commission studying off-patent antibiotics: study protocol for a randomized controlled triales
dc.typeinfo:eu-repo/semantics/articlees
dc.type.versioninfo:eu-repo/semantics/publishedVersiones
dc.rights.accessRightsinfo:eu-repo/semantics/openAccesses
dc.contributor.affiliationUniversidad de Sevilla. Departamento de Medicinaes
dc.contributor.affiliationUniversidad de Sevilla. Departamento de Microbiologíaes
dc.relation.publisherversionhttps://trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-0614-4es
dc.identifier.doi10.1186/s13063-015-0614-4es
dc.contributor.groupUniversidad de Sevilla. CTS-210: Resistencia a Antimicrobianoses
dc.journaltitleTrialses
dc.publication.volumen16es
dc.publication.issue1es
dc.publication.initialPage1es
dc.publication.endPage11es

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