dc.creator | López Cortés, Luis Eduardo | es |
dc.creator | Rosso Fernández, Clara | es |
dc.creator | Núñez Núñez, María | es |
dc.creator | Lavín Alconero, Lucía | es |
dc.creator | Bravo Ferrer, José | es |
dc.creator | Barriga, Ángel | es |
dc.creator | Delgado Valverde, María Mercedes | es |
dc.creator | Lupión Mendoza, Carmen | es |
dc.creator | Retamar Gentil, Pilar | es |
dc.creator | Rodríguez-Baño, Jesús | es |
dc.date.accessioned | 2020-05-11T13:34:13Z | |
dc.date.available | 2020-05-11T13:34:13Z | |
dc.date.issued | 2017-06-09 | |
dc.identifier.citation | López Cortés, L.E., Rosso Fernández, C., Núñez Núñez, M., Lavín Alconero, L., Bravo Ferrer, J., Barriga, Á.,...,Rodriguez Baño, J. (2017). Targeted Simplification Versus Antipseudomonal Broad-Spectrum Beta-Lactams in Patients With Bloodstream Infections Due to Enterobacteriaceae (SIMPLIFY): A Study Protocol for a Multicentre, Open-Label, Phase III Randomised, Controlled, Non-Inferiority Clinical Trial.. BMJ Open, 7 (6) | |
dc.identifier.issn | 2044-6055 | es |
dc.identifier.uri | https://hdl.handle.net/11441/96392 | |
dc.description.abstract | Introduction Within the context of antimicrobial
stewardship programmes, de-escalation of antimicrobial
therapy is one of the proposed strategies for reducing the
unnecessary use of broad-spectrum antibiotics (BSA). The
empirical treatment of nosocomial and some healthcare-
associated bloodstream infections (BSI) frequently
includes a beta-lactam with antipseudomonal activity as
monotherapy or in combination with other drugs, so there
is a great opportunity to optimise the empirical therapy
based on microbiological data. De-escalation is assumed
as standard of care for experts in infectious diseases.
However, it is less frequent than it would desirable.
Methods and analysis The SIMPLIFY trial is a
multicentre, open-label, non-inferiority phase III
randomised controlled clinical trial, designed as a
pragmatic ‘real-practice’ trial. The aim of this trial is to
demonstrate the non-inferiority of de-escalation from
an empirical beta-lactam with antipseudomonal activity
to a targeted narrow-spectrum antimicrobial in patients
with BSI due to Enterobacteriaceae. The primary outcome
is clinical cure, which will be assessed at the test of
cure visit. It will be conducted at 19 Spanish public and
university hospitals.
Ethics and dissemination Each participating centre has obtained the approval of the ethics review committee, the agreement of the directors of the institutions and authorisation from the Spanish Regulatory Agency (Agencia Española del Medicamento y Productos Sanitarios). Data will be presented at international conferences and published in peer-reviewed journals.
[Discussion] Strategies to reduce the use of BSA should be a priority. Most of the studies that support de-escalation are observational, retrospective and heterogeneous. A recent Cochrane review stated that well-designed clinical trials should be conducted to assess the safety and efficacy of de-escalation. | es |
dc.description.sponsorship | Instituto de Salud Carlos III (ISCIII): PI15/00439, integrado en el Plan Nacional de I+D+i 2013-2016 y cofinanciado por la Unión Europea (ERDF/ESF, “Investing in your future”). | es |
dc.format | application/pdf | es |
dc.format.extent | 9 | es |
dc.language.iso | eng | es |
dc.relation.ispartof | BMJ Open, 7 (6) | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
dc.subject | Enterobacteriaceae | es |
dc.subject | De-escalation | es |
dc.subject | Antimicrobial stewardship | es |
dc.subject | Bloodstream infection | es |
dc.subject | Broad-spectrum antibiotics | es |
dc.title | Targeted Simplification Versus Antipseudomonal Broad-Spectrum Beta-Lactams in Patients With Bloodstream Infections Due to Enterobacteriaceae (SIMPLIFY): A Study Protocol for a Multicentre, Open-Label, Phase III Randomised, Controlled, Non-Inferiority Clinical Trial. | es |
dc.type | info:eu-repo/semantics/article | es |
dcterms.identifier | https://ror.org/03yxnpp24 | |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Enfermería | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Medicina | es |
dc.identifier.doi | 10.1136/bmjopen-2016-015439 | es |
dc.contributor.group | Universidad de Sevilla. CTS406: Estudio de enfermedades infecciosas en la práctica clínica. | es |
dc.journaltitle | BMJ Open | es |
dc.publication.volumen | 7 | es |
dc.publication.issue | 6 | es |