The Randomized Controlled STRAWINSKI Trial : Procalcitonin-Guided Antibiotic Therapy after Stroke
Ulm, Lena (Charité - Universitaetsmedizin Berlin)
Hoffmann, Sarah (Charité - Universitaetsmedizin Berlin)
Nabavi, Darius (Vivantes Klinikum Neukoelln, Berlin)
Hermans, Marcella (Vivantes Klinikum Neukoelln, Berlin)
Mackert, Bruno-Marcel (Vivantes Auguste-Viktoria-Klinikum, Berlin)
Hamilton, Frank (Vivantes Auguste-Viktoria-Klinikum, Berlin)
Schmehl, Ingo (Unfallkrankenhaus Berlin)
Jungehuelsing, Gerhard-Jan (Charité - Universitaetsmedizin Berlin)
Montaner, Joan (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Bustamante, Alejandro (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Katan, Mira (Universitaetsspital Zürich)
Hartmann, Andreas (Klinikum Frankfurt Oder)
Ebmeyer, Stefan (Thermo Fisher Scientific BRAHMS GmbH, Hennigsdorf, Germany)
Dinter, Christiane (Thermo Fisher Scientific BRAHMS GmbH, Hennigsdorf, Germany)
Wiemer, Jan C. (Thermo Fisher Scientific BRAHMS GmbH, Hennigsdorf, Germany)
Hertel, Sabine (Thermo Fisher Scientific BRAHMS GmbH, Hennigsdorf, Germany)
Meisel, Christian (Charité - Universitaetsmedizin Berlin)
Anker, Stefan D. (University Medical Centre Goettingen)
Meisel, Andreas (Charité - Universitaetsmedizin Berlin)
Universitat Autònoma de Barcelona

Data:	2017
Resum:	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. This trial investigated whether procalcitonin (PCT) ultrasensitive (PCTus)-guided antibiotic treatment of SAP can improve functional outcome after stroke. 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 (Identifier NCT01264549). 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). 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.
Ajuts:	European Commission 201024 European Commission 202213
Nota:	Altres ajuts: This trial was supported by [...] 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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Stroke ; Pneumonia ; Antibiotic prophylaxis ; Procalcitonin ; Outcome ; Infections ; Biomarker-guided treatment
Publicat a:	Frontiers in neurology, Vol. 8 (april 2017) , ISSN 1664-2295

DOI: 10.3389/fneur.2017.00153
PMID: 28484421

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