Published online before print June 16, 2005, doi: 10.1161/01.STR.0000170644.15504.49
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(Stroke. 2005;36:1495.)
© 2005 American Heart Association, Inc.
Original Contributions |
The Early Systemic Prophylaxis of Infection After Stroke Study
A Randomized Clinical Trial
From the Stroke Unit, Hospital Clínic and Institut d’ Investigacions Biomédiques August Pi i Sunyer (IDIBAPS; A.C., V.O., M.R.), Barcelona, Spain; the Infectious Diseases Unit (J.P.H., M.V., J.M.), Hospital Clínic, Barcelona, Spain; the Pharmacology and Toxicology Department, Consejo Superior de Investigaciones Científicas (IIBB-CSIC) and IDIBAPS (A.M.P.), Barcelona, Spain; and the Clinical Pharmacology Unit-Unitat d’Avaluació I Suport de Projectes (UASP; F.T.), Hospital Clínic, Barcelona, Spain.
Correspondence to Ángel Chamorro, MD, PhD, Stroke Unit, Hospital Clínic, Villarroel 170. 08036-Barcelona, Spain. E-mail achamorro{at}ub.edu
Background 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.
Key Words: randomized controlled trials • stroke
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