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

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ClinicalTrials.gov Identifier: NCT01264549
Recruitment Status : Completed
First Posted : December 22, 2010
Last Update Posted : January 4, 2022
Sponsor:
Collaborators:
Brahms AG
NeuroCure Clinical Research Center, Charite, Berlin
Information provided by (Responsible Party):
Andreas Meisel, Charite University, Berlin, Germany

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Device: Procalcitonin assay - B.R.A.H.M.S PCT ultrasensitive Kryptor Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stroke Adverse Outcome is Associated With Nosocomial Infections: PCTus- Guided Antibacterial Therapy in Severe Ischemic Stroke Patients
Study Start Date : December 2010
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PCT guided arm Device: Procalcitonin assay - B.R.A.H.M.S PCT ultrasensitive Kryptor
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 Name: Procalcitonin
No Intervention: Control
Standard treatment


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01264549


Locations
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Germany
Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
Berlin, Germany
Unfallkrankenhaus Berlin Neurologie
Berlin, Germany
Vivantes Auguste Viktoria Klinikum Neurologie
Berlin, Germany
Vivantes Neukölln Neurologie
Berlin, Germany
Klinikum Frankfurt (Oder) Neurologie
Frankfurt (Oder), Germany
Spain
Hospital Vall d'Hebron
Barcelona, Spain
Sponsors and Collaborators
Charite University, Berlin, Germany
Brahms AG
NeuroCure Clinical Research Center, Charite, Berlin
Investigators
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Principal Investigator: Andreas Meisel, MD Charité University Berlin (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
Principal Investigator: Stefan Anker, MD PhD Charité University Berlin (Dept of Cardiology)
More Information
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Publications of Results:

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Responsible Party: Andreas Meisel, Prof. Dr. Andreas Meisel, Charité University, Berlin, Germany (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC), Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01264549    
Other Study ID Numbers: STRAWINSKI
First Posted: December 22, 2010    Key Record Dates
Last Update Posted: January 4, 2022
Last Verified: December 2021
Keywords provided by Andreas Meisel, Charite University, Berlin, Germany:
ischemic stroke
stroke-associated infections
biomarkers
PCT
immune and infection parameters
Additional relevant MeSH terms:
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Infections
Cross Infection
Stroke
Ischemic Stroke
Cerebral Infarction
Ischemia
Disease Attributes
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Infarction
Necrosis
Iatrogenic Disease