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The Randomized Controlled STRAWINSKI Trial: Procalcitonin-Guided Antibiotic Therapy after Stroke Ulm, Lena Hoffmann, Sarah Nabavi, Darius Hermans, Marcella Mackert, Bruno-Marcel Hamilton, Frank Montaner Villalonga, Joan Bustamante Rangel, Alejandro Institut Català de la Salut [Ulm L] NeuroCure Clinical Research Center, Charité – Universitaetsmedizin Berlin, Berlin, Germany. Centre for Clinical Research, The University of Queensland, Brisbane, QLD, Australia. Department of Neurology and Center for Stroke Research Berlin, Charité – Universitaetsmedizin Berlin, Berlin, Germany. [Hoffmann S] NeuroCure Clinical Research Center, Charité – Universitaetsmedizin Berlin, Berlin, Germany. Department of Neurology and Center for Stroke Research Berlin, Charité – Universitaetsmedizin Berlin, Berlin, Germany. [Nabavi D, Hermans M] Department of Neurology, Vivantes Klinikum Neukoelln, Berlin, Germany. [Mackert BM, Hamilton F] Department of Neurology, Vivantes Auguste-Viktoria-Klinikum, Berlin, Germany. [Montaner J, Bustamante A] Grup Malalties neurovasculars, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain Vall d'Hebron Barcelona Hospital Campus Pneumònia Medicaments - Administració Infart de miocardi DISEASES::Respiratory Tract Diseases::Lung Diseases::Pneumonia Other subheadings::Other subheadings::Other subheadings::/drug therapy DISEASES::Cardiovascular Diseases::Heart Diseases::Myocardial Ischemia::Myocardial Infarction ENFERMEDADES::enfermedades respiratorias::enfermedades pulmonares::neumonía Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia ENFERMEDADES::enfermedades cardiovasculares::enfermedades cardíacas::isquemia miocárdica::infarto de miocardio Profilaxi antibiòtica; Infeccions; Pneumònia Profilaxis antibiótica; Infecciones; Neumonía Antibiotic prophylaxis; Infections; Pneumonia Background: Pneumonia is among the most common acute complications after stroke and is associated with poor long-term outcome. Biomarkers may help identifying stroke patients at high risk for developing stroke-associated pneumonia (SAP) and to guide early treatment. Aims: This trial investigated whether procalcitonin (PCT) ultrasensitive (PCTus)-guided antibiotic treatment of SAP can improve functional outcome after stroke. Methods: In this international, multicenter, randomized, controlled clinical trial with blinded assessment of outcomes, patients with severe ischemic stroke in the middle cerebral artery territory were randomly assigned within 40 h after symptom onset to PCTus-based antibiotic therapy guidance in addition to stroke unit care or standard stroke unit care alone. The primary endpoint was functional outcome at 3 months, defined according to the modified Rankin Scale (mRS) and dichotomized as acceptable (≤4) or unacceptable (≥5). Secondary endpoints included usage of antibiotics, infection rates, days of fever, and mortality. The trial was registered with http://ClinicalTrials.gov (Identifier NCT01264549). Results: In the intention-to-treat-analysis based on 227 patients (112 in PCT and 115 in control group), 197 patients completed the 3-month follow-up. Adherence to PCT guidance was 65%. PCT-guided therapy did not improve functional outcome as measured by mRS (odds ratio 0.79; 95% confidence interval 0.45–1.35, p = 0.47). Pneumonia rate and mortality were similar in both groups. Days with fever tended to be lower (p = 0.055), whereas total number of days treated with antibiotics were higher (p = 0.004) in PCT compared to control group. A post hoc analysis including all PCT values in the intention-to-treat population demonstrated a significant increase on the first day of infection in patients with pneumonia and sepsis compared to patients with urinary tract infections or without infections (p < 0.0001). Conclusion: PCTus-guided antibiotic therapy did not improve functional outcome at 3 months after severe ischemic stroke. PCT is a promising biomarker for early detection of pneumonia and sepsis in acute stroke patients. This trial was supported by the European Union (FP7/2008-2013; 201024 and 202213), the German Ministry for Health and Education (01EO0801), the German Research Foundation (Exc257, SFB-TRR84, UL423/1-1), and Thermo Fisher Scientific BRAHMS GmbH, Germany. 2021-04-29T11:19:27Z 2021-04-29T11:19:27Z 2017-04-24 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Ulm L, Hoffmann S, Nabavi D, Hermans M, Mackert BM, Hamilton F, et al. The Randomized Controlled STRAWINSKI Trial: Procalcitonin-Guided Antibiotic Therapy after Stroke. Front Neurol. 2017 Apr 24;8:153. 1664-2295 https://hdl.handle.net/11351/5928 10.3389/fneur.2017.00153 28484421 000399981200001 http://hdl.handle.net/11351/5928 eng Frontiers in Neurology;8 http://journal.frontiersin.org/article/10.3389/fneur.2017.00153/full info:eu-repo/grantAgreement/EC/FP7/201024 info:eu-repo/grantAgreement/EC/FP7/202213 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess application/pdf Frontiers Media Scientia