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

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:

MedlinePlus related topics: Antibiotics

U.S. FDA Resources

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:	200
Study Start Date:	December 2010
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	July 2013 (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

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

Contacts

Contact: Andreas Meisel, MD	+49 30 450 ext 560026	andreas.meisel@charite.de
Contact: Lena Ulm, MD	+49 30 450 ext 539778	lena.ulm@charite.de

Locations

Germany
Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)	Recruiting
Berlin, Germany
Contact: Lena Ulm, MD +49 30 450 ext 539778 lena.ulm@charite.de
Sub-Investigator: Lena Ulm, MD
Vivantes Neukölln Neurologie	Recruiting
Berlin, Germany
Contact: Darius Nabavi, MD
Vivantes Auguste Viktoria Klinikum Neurologie	Recruiting
Berlin, Germany
Contact: Bruno-Marcel Mackert, MD
Unfallkrankenhaus Berlin Neurologie	Recruiting
Berlin, Germany
Contact: Ingo Schmehl, MD
Klinikum Frankfurt (Oder) Neurologie	Recruiting
Frankfurt (Oder), Germany
Contact: Andreas Hartmann, MD
Sankt Josefs Krankenhaus Potsdam Neurologie	Withdrawn
Potsdam, Germany
Spain
Hospital Vall d'Hebron	Recruiting
Barcelona, Spain
Contact: Joan Montana, MD

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

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:	February 15, 2013
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:

Ischemia
Stroke
Cerebral Infarction
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 May 22, 2013