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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Brahms AG
Information provided by (Responsible Party):
Andreas Meisel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01264549
First received: December 21, 2010
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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 Intervention
Ischemic Stroke
Device: Procalcitonin assay - B.R.A.H.M.S PCT ultrasensitive Kryptor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stroke Adverse Outcome is Associated With Nosocomial Infections: PCTus- Guided Antibacterial Therapy in Severe Ischemic Stroke Patients

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Modified Rankin scale (mRS 0-6) score 0-4 adjusted for baseline modified Rankin score [ Time Frame: 3 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    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:
  • Proportion of patients receiving any antibiotic therapy [ Time Frame: 3 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To assess the proportion of patients receiving any antibiotic therapy for any duration within 90 days.

  • Modified Rankin scale adjusted for baseline modified Rankin score [ Time Frame: 3 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To assess the Modified Rankin scale at day 90 adjusted for baseline modified Rankin score.

  • Barthel Index adjusted for baseline Barthel Index [ Time Frame: 3 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To assess the Barthel Index (BI 0-100) at day 90 adjusted for baseline Barthel Index.

  • Modified Rankin scale (mRS) score 0-4 adjusted for baseline modified Rankin score [ Time Frame: 6 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To assess the proportion of patients with a modified Rankin scale (mRS) score 0-4 at day 180 adjusted for baseline modified Rankin score.

  • Modified Rankin scale adjusted for baseline modified Rankin score [ Time Frame: 6 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To assess the modified Rankin scale at day 180 adjusted for baseline modified Rankin score.

  • Barthel Index adjusted for baseline Barthel Index [ Time Frame: 6 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To assess the Barthel Index at day 180 adjusted for baseline Barthel Index.

  • Days alive and out of hospital [ Time Frame: 3 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To assess the days alive and out of hospital at day 90.

  • Time to first event of death, re-hospitalization or recurrent stroke [ Time Frame: within 6 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To assess the time to first event of death, re-hospitalization or recurrent stroke.

  • Proportion of events of post stroke infections [ Time Frame: within 7 days after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To assess the proportion of events of post stroke infections to day 7.

  • Proportion of events of post stroke infection or death [ Time Frame: within 7 days after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To assess the proportion of events of post stroke infection or death to day 7.

  • Medium number of days with fever (≥ 37,5°C) per patient [ Time Frame: within 7 days after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To assess the medium number of days with fever (≥ 37,5°C) per patient to day 7.

  • Stroke volume analysis [ Time Frame: 6 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To investigate the effect of an early PCT-guided antiinfective therapy on stroke volume.

  • Length of hospital stay [ Time Frame: on discharge ] [ Designated as safety issue: No ]
    To assess the length of hospital stay after acute stroke.

  • Hospital discharge disposition [ Time Frame: on discharge ] [ Designated as safety issue: No ]
    To assess the disposition on hospital discharge.

  • shift analysis of the mRS [ Designated as safety issue: No ]

Estimated Enrollment: 230
Study Start Date: December 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01264549

Locations
Germany
Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
Berlin, Germany
Vivantes Neukölln Neurologie
Berlin, Germany
Vivantes Auguste Viktoria Klinikum Neurologie
Berlin, Germany
Unfallkrankenhaus Berlin 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
Investigators
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

No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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     History of Changes
Other Study ID Numbers: STRAWINSKI
Study First Received: December 21, 2010
Last Updated: May 28, 2014
Health Authority: Germany: Ethics Commission of the Charité University Berlin

Keywords provided by Charite University, Berlin, Germany:
ischemic stroke
stroke-associated infections
biomarkers
PCT
immune and infection parameters

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Ischemia
Cross Infection
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Infection
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014