13 research outputs found

    Multicentre, randomised, open-label, phase IV-III study to evaluate the efficacy of cloxacillin plus fosfomycin versus cloxacillin alone in adult patients with methicillin-susceptible Staphylococcus aureus bacteraemia: study protocol for the SAFO trial

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    Introduction: Methicillin-susceptible Staphylococcus aureus (MSSA) bacteraemia is a frequent condition, with high mortality rates. There is a growing interest in identifying new therapeutic regimens able to reduce therapeutic failure and mortality observed with the standard of care of beta-lactam monotherapy. In vitro and small-scale studies have found synergy between cloxacillin and fosfomycin against S. aureus. Our aim is to test the hypothesis that cloxacillin plus fosfomycin achieves higher treatment success than cloxacillin alone in patients with MSSA bacteraemia. Methods: We will perform a superiority, randomised, open-label, phase IV-III, two-armed parallel group (1:1) clinical trial at 20 Spanish tertiary hospitals. Adults (≥18 years) with isolation of MSSA from at least one blood culture ≤72 hours before inclusion with evidence of infection, will be randomly allocated to receive either cloxacillin 2 g/4-hour intravenous plus fosfomycin 3 g/6-hour intravenous or cloxacillin 2 g/4-hour intravenous alone for 7 days. After the first week, sequential treatment and total duration of antibiotic therapy will be determined according to clinical criteria by the attending physician. Primary endpoints: (1) Treatment success at day 7, a composite endpoint comprising all the following criteria: patient alive, stable or with improved quick-Sequential Organ Failure Assessment score, afebrile and with negative blood cultures for MSSA at day 7. (2) Treatment success at test of cure (TOC) visit: patient alive and no isolation of MSSA in blood culture or at another sterile site from day 8 until TOC (12 weeks after randomisation). We assume a rate of treatment success of 74% in the cloxacillin group. Accepting alpha risk of 0.05 and beta risk of 0.2 in a two-sided test, 183 subjects will be required in each of the control and experimental groups to obtain statistically significant difference of 12% (considered clinically significant). Ethics and dissemination: Ethical approval has been obtained from the Ethics Committee of Bellvitge University Hospital (AC069/18) and from the Spanish Medicines and Healthcare Product Regulatory Agency (AEMPS, AC069/18), and is valid for all participating centres under existing Spanish legislation. The results will be presented at international meetings and will be made available to patients and funders

    Contexto histórico de la obra del Dr. Simarro

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    Se señala la fuerte gravitación que en la infancia y adolescencia de Luis Simarro tuvieron las formas de vida y la mentalidad románticas, vigentes en la España de los años cincuenta y sesenta del siglo XIX. Será la época de la Restauración la que preste contexto histórico a su vida y a su obra: determinados momentos de la trayectoria biográfica de Simarro son de gran valor simbólico como trasunto de otras tantas encrucijadas en la trayectoria de la España de la Restauración; especialmente el cambio de sensibilidad de los años noventa, orientado a la búsqueda de un conocimiento más profundo del alma humana y a una creciente atención a los pobres, a los enfermos y a los marginados, en sintonía con la orientación global del quehacer del Dr. Simarro

    Discurso de investidura como Doctor Honoris Causa del Prof. José María Jover Zamora

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    Dicurso pronunciado por la Profª. Dra. Dª. Guadalupe Gómez-Ferrer en nombre de su esposo el Prof. José María Jover Zamora en el Acto de su Investidura como Doctor Honoris Caus

    La guerra de la independencia española y los sitios de Zaragoza

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    Na portadilla: Historia de la Guerra,
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