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dc.creatorRosso Fernández, Claraes
dc.creatorSojo Dorado, Jesúses
dc.creatorBarriga Barros, Ángeles
dc.creatorLavín Alconero, Lucíaes
dc.creatorPalacios, Zairaes
dc.creatorLópez Hernández, Inmaculadaes
dc.creatorPascual Hernández, Álvaroes
dc.creatorRodríguez-Baño, Jesúses
dc.date.accessioned2017-05-16T09:15:24Z
dc.date.available2017-05-16T09:15:24Z
dc.date.issued2015
dc.identifier.issn2044-6055es
dc.identifier.urihttp://hdl.handle.net/11441/59867
dc.description.abstractIntroduction Finding therapeutic alternatives to carbapenems in infections caused by extended-spectrum β-lactamase-producing Escherichia coli (ESBL-EC) is imperative. Although fosfomycin was discovered more than 40 years ago, it was not investigated in accordance with current standards and so is not used in clinical practice except in desperate situations. It is one of the so-called neglected antibiotics of high potential interest for the future. Methods and analysis The main objective of this project is to demonstrate the clinical non-inferiority of intravenous fosfomycin with regard to meropenem for treating bacteraemic urinary tract infections (UTI) caused by ESBL-EC. This is a ‘real practice’ multicentre, open-label, phase III randomised controlled trial, designed to compare the clinical and microbiological efficacy, and safety of intravenous fosfomycin (4 g/6 h) and meropenem (1 g/8 h) as targeted therapy for this infection; a change to oral therapy is permitted after 5 days in both arms, in accordance with predetermined options. The study design follows the latest recommendations for designing trials investigating new options for multidrug-resistant bacteria. Secondary objectives include the study of fosfomycin concentrations in plasma and the impact of both drugs on intestinal colonisation by multidrug-resistant Gram-negative bacilli. Ethics and dissemination Ethical approval was obtained from the Andalusian Coordinating Institutional Review Board (IRB) for Biomedical Research (Referral Ethics Committee), which obtained approval from the local ethics committees at all participating sites in Spain (22 sites). Data will be presented at international conferences and published in peer-reviewed journals. Discussion This project is proposed as an initial step in the investigation of an orphan antimicrobial of low cost with high potential as a therapeutic alternative in common infections such as UTI in selected patients. These results may have a major impact on the use of antibiotics and the development of new projects with this drug, whether as monotherapy or combination therapy.es
dc.formatapplication/pdfes
dc.language.isoenges
dc.publisherBMJ Publishing Groupes
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 Internacional*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/*
dc.subjectBacteriologyes
dc.subjectGenitourinary medicinees
dc.titleFosfomycin versus meropenem in bacteraemic urinary tract infections caused by extended-spectrum β-lactamase-producing Escherichia coli (FOREST): study protocol for an investigator-driven randomised 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 Microbiologíaes
dc.contributor.affiliationUniversidad de Sevilla. Departamento de Medicinaes
dc.relation.publisherversionhttp://dx.doi.org/ 10.1136/bmjopen-2014-007363es
dc.identifier.doi10.1136/bmjopen-2014-007363es
idus.format.extent11 p.es
dc.journaltitleBMJ Openes
dc.publication.volumen5es
dc.publication.issue3es
dc.publication.initialPage1es
dc.publication.endPage10es

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