STRoke Adverse outcome is associated WIth NoSocomial Infections (STRAWINSKI): procalcitonin ultrasensitive-guided antibacterial therapy in severe ischaemic stroke patients – rationale and protocol for a randomized controlled trial

Authors

  • Lena Ulm,

    1. Neurocure Clinical Research Center, Charité – Universitätsmedizin Berlin, Berlin, Germany
    2. Department of Neurology and Center for Stroke Research Berlin, Charité -Universitätsmedizin Berlin, Berlin, Germany
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    • Equal contribution.
  • Stephanie Ohlraun,

    1. Neurocure Clinical Research Center, Charité – Universitätsmedizin Berlin, Berlin, Germany
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    • Equal contribution.
  • Hendrik Harms,

    1. Neurocure Clinical Research Center, Charité – Universitätsmedizin Berlin, Berlin, Germany
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  • Sarah Hoffmann,

    1. Neurocure Clinical Research Center, Charité – Universitätsmedizin Berlin, Berlin, Germany
    2. Department of Neurology and Center for Stroke Research Berlin, Charité -Universitätsmedizin Berlin, Berlin, Germany
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  • Juliane Klehmet,

    1. Department of Neurology and Center for Stroke Research Berlin, Charité -Universitätsmedizin Berlin, Berlin, Germany
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  • Stefan Ebmeyer,

    1. Thermo Fisher Scientific BRAHMS GmbH, Hennigsdorf, Germany
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  • Oliver Hartmann,

    1. Thermo Fisher Scientific BRAHMS GmbH, Hennigsdorf, Germany
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  • Christian Meisel,

    1. Department of Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany
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  • Stefan D. Anker,

    1. Department of Cardiology, Charité – Universitätsmedizin Berlin, Berlin, Germany
    2. Centre for Clinical and Basic Research, IRCCS, San Raffaele, Rome, Italy
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  • Andreas Meisel

    Corresponding author
    1. Department of Neurology and Center for Stroke Research Berlin, Charité -Universitätsmedizin Berlin, Berlin, Germany
    • Neurocure Clinical Research Center, Charité – Universitätsmedizin Berlin, Berlin, Germany
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  • Conflict of interest: O.H. is employed as a biostatistician by Thermo Fisher Scientific BRAHMS GmbH, Germany. S.E. is responsible for the technical setup of the PCTus-measurements and contributed his medical expertise and knowledge about PCT to the study protocol.

Correspondence: Andreas Meisel, Department of Neurology, Charité – Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany.

E-mail: andreas.meisel@charite.de

Abstract

Rationale

Stroke-associated pneumonia is one of the most common causes of poor outcome in stroke patients. Clinical signs and laboratory parameters of stroke-associated infections are often inconclusive. Biomarkers may help to identify stroke patients at high risk for pneumonia and to guide physicians in an early antibiotic treatment, thereby improving stroke outcome.

Aim

The aim of the present study is to investigate whether procalcitonin ultrasensitive-guided antibiotic treatment improves functional outcome after severe ischaemic stroke by early treatment of pneumonia.

Design

STRAWINSKI is an investigator-initiated, multicentre, randomized, controlled trial with blinded assessment of outcome comparing procalcitonin ultrasensitive-guided antibiotic treatment with standard care.

Study

200 patients with ischaemic stroke in the middle cerebral artery territory and a score >9 on the National Institutes of Health Stroke Scale will be included and randomly assigned to two groups. One group will receive procalcitonin-based antibiotic therapy guidance; the other group will receive standard stroke unit care.

Outcomes

The primary endpoint is functional outcome at day 90 after stroke on the modified Rankin Scale, dichotomized as favourable (0–4) or unfavourable outcome (5–6). Secondary endpoints are time to first event of death, rehospitalization, or recurrent stroke; death rate, infection rate, and days with fever up to day 7; length of hospital stay and hospital discharge disposition; shift analysis of the modified Rankin Scale; Barthel Index and days alive and out of hospital at day 90; use of antibiotics until day 90; and modified Rankin Scale, Barthel Index, and infarct volume at day 180.

Ancillary