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Por favor, use este identificador para citar o enlazar a este item: http://hdl.handle.net/10261/116853
Título

The early systemic prophylaxis of infection after stroke study: A randomized clinical trial

AutorChamorro, Ángel; Horcajadas, Juan Pablo; Obach, Víctor; Vargas, Martha; Revilla, Marina; Torres, Ferran; Cervera, Álvaro; Planas, Anna M. ; Mensa, Josep
Palabras claveRandomized controlled trials
Stroke
Fecha de publicaciónjul-2005
EditorLippincott Williams & Wilkins
CitaciónStroke, a journal of cerebral circulation 36(7): 1495-1500 (2005)
ResumenBackground and Purpose - Early infection after stroke is frequent but the clinical value of antibiotic prophylaxis in acute stroke has never been explored. Objective and Methods - The Early Systemic Prophylaxis of Infection After Stroke (ESPIAS) is a randomized, double-blind, placebo-controlled study of antibiotic prophylaxis in patients older than 18 years with nonseptic ischemic or hemorrhagic stroke enrolled within 24 hours from clinical onset. Interventions included intravenous levofloxacin (500 mg/100 mL/d, for 3 days) or placebo (0.9% physiological serum) in addition to optimal care. A sample size of 240 patients was calculated to identify a 15% absolute risk reduction of the primary outcome measure, which was the incidence of infection at day 7 after stroke. Secondary outcome measures were neurological outcome and mortality at day 90. Results - Based on a preplanned futility analysis, the study was interrupted prematurely when 136 patients had been included. Levofloxacin and placebo patients had a cumulative rate of infection of 6% and 6% (P=0.96) at day 1; 10% and 12% (P=0.83) at day 2; 12% and 15% (P=0.66) at day 3; 16% and 19% (P=0.82) at day 7; and 30% and 33% (P=0.70), at day 90. Using logistic regression, favorable outcome at day 90 was inversely associated with baseline National Institutes of Health Stroke Scale (OR, 0.72; 95% CI, 0.59 to 0.89; P=0.002) and allocation to levofloxacin (OR, 0.19; 95% CI, 0.04 to 0.87; P=0.03). Conclusions - Prophylactic administration of levofloxacin (500 mg/100 mL/day for 3 days) is not better than optimal care for the prevention of infections in patients with acute stroke. © 2005 American Heart Association, Inc.
Versión del editorhttp://dx.doi.org/10.1161/01.STR.0000170644.15504.49
URIhttp://hdl.handle.net/10261/116853
DOI10.1161/01.STR.0000170644.15504.49
Identificadoresdoi: 10.1161/01.STR.0000170644.15504.49
issn: 0039-2499
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