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NCT Number: NCT01264549

Stroke Adverse Outcome is Associated With Nosocomial Infections: PCTus- Guided Antibacterial Therapy in Severe Ischemic Stroke Patients (STRAWINSKI)

Development of stroke associated pneumonia (SAP) has a detrimental effect on stroke outcome. Biomarker-guided antibiotic treatment of patients at high risk for pneumonia may help to improve stroke outcome. Therefore, the investigators will evaluate whether intensified infection monitoring via Procalcitonin guiding an early standardized antibiotic treatment improves functional outcome after stroke compared with standard therapy based on current guidelines.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC), Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥18 years
  • stroke onset within the last 40 hours before randomisation
  • clinical diagnosis of a severe (NIHSS > 9), non-lacunar stroke in the middle cerebral artery territory
  • consent given by the patient or by his/her legitimate representative where patients are incapable of giving consent themselves

Exclusion criteria

  • CT evidence of an intracerebral haemorrhage or a lacunar infarct as the probable cause of the current illness
  • Antibiotic use within the last 10 days
  • Suspected life expectancy of < 3 months
  • Participation in other interventional trials (on pharmaceuticals or medical devices)
  • Pregnancy, lactation
  • Pre-stroke mRS score ≥ 4

Treatment and study plan

Procalcitonin assay - B.R.A.H.M.S PCT ultrasensitive Kryptor

Device

The physician will be given access to a PCT value for Day 1 - 7. Depending on the PCT concentrations, the protocol recommends or discourages from the use of antibiotics

Other names: Procalcitonin

Primary outcomes

  1. Modified Rankin scale (mRS 0-6) score 0-4 adjusted for baseline modified Rankin score

    Time frame: 3 months after onset of symptoms (stroke)

    To assess the proportion of patients with a modified Rankin scale (mRS 0-6) score 0-4 at day 90 adjusted for baseline modified Rankin score.

Secondary outcomes

  1. Proportion of patients receiving any antibiotic therapy

    Time frame: 3 months after onset of symptoms (stroke)

    To assess the proportion of patients receiving any antibiotic therapy for any duration within 90 days.

  2. Modified Rankin scale adjusted for baseline modified Rankin score

    Time frame: 3 months after onset of symptoms (stroke)

    To assess the Modified Rankin scale at day 90 adjusted for baseline modified Rankin score.

  3. Barthel Index adjusted for baseline Barthel Index

    Time frame: 3 months after onset of symptoms (stroke)

    To assess the Barthel Index (BI 0-100) at day 90 adjusted for baseline Barthel Index.

  4. Modified Rankin scale (mRS) score 0-4 adjusted for baseline modified Rankin score

    Time frame: 6 months after onset of symptoms (stroke)

    To assess the proportion of patients with a modified Rankin scale (mRS) score 0-4 at day 180 adjusted for baseline modified Rankin score.

  5. Modified Rankin scale adjusted for baseline modified Rankin score

    Time frame: 6 months after onset of symptoms (stroke)

    To assess the modified Rankin scale at day 180 adjusted for baseline modified Rankin score.

  6. Barthel Index adjusted for baseline Barthel Index

    Time frame: 6 months after onset of symptoms (stroke)

    To assess the Barthel Index at day 180 adjusted for baseline Barthel Index.

  7. Days alive and out of hospital

    Time frame: 3 months after onset of symptoms (stroke)

    To assess the days alive and out of hospital at day 90.

  8. Time to first event of death, re-hospitalization or recurrent stroke

    Time frame: within 6 months after onset of symptoms (stroke)

    To assess the time to first event of death, re-hospitalization or recurrent stroke.

  9. Proportion of events of post stroke infections

    Time frame: within 7 days after onset of symptoms (stroke)

    To assess the proportion of events of post stroke infections to day 7.

  10. Proportion of events of post stroke infection or death

    Time frame: within 7 days after onset of symptoms (stroke)

    To assess the proportion of events of post stroke infection or death to day 7.

  11. Medium number of days with fever (≥ 37,5°C) per patient

    Time frame: within 7 days after onset of symptoms (stroke)

    To assess the medium number of days with fever (≥ 37,5°C) per patient to day 7.

  12. Stroke volume analysis

    Time frame: 6 months after onset of symptoms (stroke)

    To investigate the effect of an early PCT-guided antiinfective therapy on stroke volume.

  13. Length of hospital stay

    Time frame: on discharge

    To assess the length of hospital stay after acute stroke.

  14. Hospital discharge disposition

    Time frame: on discharge

    To assess the disposition on hospital discharge.

  15. shift analysis of the mRS

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Brahms AG
  • NeuroCure Clinical Research Center, Charite, Berlin

Registry information

Official study title

Stroke Adverse Outcome is Associated With Nosocomial Infections: PCTus- Guided Antibacterial Therapy in Severe Ischemic Stroke Patients

Acronym: STRAWINSKI

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 22, 2010
Registry last updated
Jan 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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