on June 16, 2005
Published online before print June 16, 2005, doi: 10.1161/01.STR.0000170644.15504.49
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Submitted on March 10, 2005
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. * To whom correspondence should be addressed. 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.
Revised on April 11, 2005
Accepted on April 27, 2005
The Early Systemic Prophylaxis of Infection After Stroke Study. A Randomized Clinical Trial
A. Chamorro MD*;
Key words: randomized controlled trials • stroke
This article has been cited by other articles:
 |
|
 |
|
  D. van de Beek, E. F. M. Wijdicks, F. H. Vermeij, R. J. de Haan, J. M. Prins, L. Spanjaard, D. W. J. Dippel, and P. J. Nederkoorn Preventive Antibiotics for Infections in Acute Stroke: A Systematic Review and Meta-analysis Arch Neurol, September 1, 2009; 66(9): 1076 - 1081. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 D. Summers, A. Leonard, D. Wentworth, J. L. Saver, J. Simpson, J. A. Spilker, N. Hock, E. Miller, P. H. Mitchell, and on behalf of the American Heart Association Counci Comprehensive Overview of Nursing and Interdisciplinary Care of the Acute Ischemic Stroke Patient: A Scientific Statement From the American Heart Association Stroke, August 1, 2009; 40(8): 2911 - 2944. [Full Text] [PDF]
|
|
|
|
 |
|
 J. R. Caso, O. Hurtado, M. P. Pereira, B. Garcia-Bueno, L. Menchen, L. Alou, M. L. Gomez-Lus, M. A. Moro, I. Lizasoain, and J. C. Leza Colonic bacterial translocation as a possible factor in stress-worsening experimental stroke outcome Am J Physiol Regulatory Integrative Comp Physiol, April 1, 2009; 296(4): R979 - R985. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
X. Urra, A. Cervera, V. Obach, N. Climent, A. M. Planas, and A. Chamorro Monocytes Are Major Players in the Prognosis and Risk of Infection After Acute Stroke Stroke, April 1, 2009; 40(4): 1262 - 1268. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 K. B. Lee Can the Use of Oral Minocycline Improve Ischemic Stroke Outcomes? Journal of Pharmacy Practice, April 1, 2008; 21(2): 159 - 164. [Abstract] [PDF]
|
|
|
|
|
|
S. Schwarz, F. Al-Shajlawi, C. Sick, S. Meairs, and M. G. Hennerici Effects of Prophylactic Antibiotic Therapy With Mezlocillin Plus Sulbactam on the Incidence and Height of Fever After Severe Acute Ischemic Stroke: The Mannheim Infection in Stroke Study (MISS) Stroke, April 1, 2008; 39(4): 1220 - 1227. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. Vogelgesang, U. Grunwald, S. Langner, R. Jack, B. M. Broker, C. Kessler, and A. Dressel Analysis of Lymphocyte Subsets in Patients With Stroke and Their Influence on Infection After Stroke Stroke, January 1, 2008; 39(1): 237 - 241. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 Y. Lampl, M. Boaz, R. Gilad, M. Lorberboym, R. Dabby, A. Rapoport, M. Anca-Hershkowitz, and M. Sadeh Minocycline treatment in acute stroke: An open-label, evaluator-blinded study Neurology, October 2, 2007; 69(14): 1404 - 1410. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 H. P. Adams Jr, G. del Zoppo, M. J. Alberts, D. L. Bhatt, L. Brass, A. Furlan, R. L. Grubb, R. T. Higashida, E. C. Jauch, C. Kidwell, et al. Guidelines for the Early Management of Adults With Ischemic Stroke: A Guideline From the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: The American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists. Circulation, May 22, 2007; 115(20): e478 - e534. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
H. P. Adams Jr, G. del Zoppo, M. J. Alberts, D. L. Bhatt, L. Brass, A. Furlan, R. L. Grubb, R. T. Higashida, E. C. Jauch, C. Kidwell, et al. Guidelines for the Early Management of Adults With Ischemic Stroke: A Guideline From the American Heart Association/ American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: The American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists Stroke, May 1, 2007; 38(5): 1655 - 1711. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. Chamorro, X. Urra, and A. M. Planas Infection After Acute Ischemic Stroke: A Manifestation of Brain-Induced Immunodepression Stroke, March 1, 2007; 38(3): 1097 - 1103. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 G Gromadzka, I Sarzynska-Dlugosz, and A Czlonkowska IL1RN intron 2 polymorphism caused by variable number tandem repeats is associated with 1-year outcome in patients with ischaemic stroke J. Neurol. Neurosurg. Psychiatry, February 1, 2007; 78(2): 183 - 186. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
U. Dirnagl, J. Klehmet, J. S. Braun, H. Harms, C. Meisel, T. Ziemssen, K. Prass, and A. Meisel Stroke-Induced Immunodepression: Experimental Evidence and Clinical Relevance Stroke, February 1, 2007; 38(2): 770 - 773. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A Chamorro, S Amaro, M Vargas, V Obach, A Cervera, F Torres, and A M Planas Interleukin 10, monocytes and increased risk of early infection in ischaemic stroke. J. Neurol. Neurosurg. Psychiatry, November 1, 2006; 77(11): 1279 - 1281. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
K. Prass, J. S. Braun, U. Dirnagl, C. Meisel, and A. Meisel Stroke Propagates Bacterial Aspiration to Pneumonia in a Model of Cerebral Ischemia Stroke, October 1, 2006; 37(10): 2607 - 2612. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. Chamorro, M. Vargas, and J. Mensa Response to Letter by Kwan et al Stroke, July 1, 2006; 37(7): 1657 - 1657. [Full Text] [PDF]
|
|
|
|
|
|
J. Kwan, H. C. Roberts, and N. Englyst Do We Really Understand the Pathophysiology and Clinical Impact of Poststroke Infection? Stroke, July 1, 2006; 37(7): 1656 - 1656. [Full Text] [PDF]
|
|
|
|
|
|
M. Vargas, J. P. Horcajada, V. Obach, M. Revilla, A. Cervera, F. Torres, A. M. Planas, J. Mensa, and A. Chamorro Clinical Consequences of Infection in Patients With Acute Stroke: Is It Prime Time for Further Antibiotic Trials? Stroke, February 1, 2006; 37(2): 461 - 465. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. Chamorro and J. Hallenbeck The Harms and Benefits of Inflammatory and Immune Responses in Vascular Disease Stroke, February 1, 2006; 37(2): 291 - 293. [Full Text] [PDF]
|
|