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

This study is currently recruiting participants.

Verified February 2013 by Charite University, Berlin, Germany

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: February 15, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 21, 2010

Last Updated Date

February 15, 2013

Start Date ^ICMJE

December 2010

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01264549 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Ischemic Stroke

Intervention ^ICMJE

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

Study Arm (s)

Experimental: PCT guided arm
Intervention: Device: Procalcitonin assay - B.R.A.H.M.S PCT ultrasensitive Kryptor
No Intervention: Control
Standard treatment

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

December 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Germany, Spain

Administrative Information

NCT Number ^ICMJE

NCT01264549

Other Study ID Numbers ^ICMJE

STRAWINSKI

Has Data Monitoring Committee

Responsible Party

Andreas Meisel, Charite University, Berlin, Germany

Study Sponsor ^ICMJE

Charite University, Berlin, Germany

Collaborators ^ICMJE

Brahms AG

Investigators ^ICMJE

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)

Information Provided By

Charite University, Berlin, Germany

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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