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

Not Applicable

Completed

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

• Registration Number: NCT01264549
• Lead Sponsor: Charite University, Berlin, Germany

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 available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-21
• Study First Submitted QC: 2010-12-21
• Study First Posted: 2010-12-22
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-15
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCT guided arm	Procalcitonin assay - B.R.A.H.M.S PCT ultrasensitive Kryptor	-

Primary Outcome Measures

Name	Time	Method
Modified Rankin scale (mRS 0-6) score 0-4 adjusted for baseline modified Rankin score	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

Name	Time	Method
Hospital discharge disposition	on discharge	To assess the disposition on hospital discharge.
Barthel Index adjusted for baseline Barthel Index	6 months after onset of symptoms (stroke)	To assess the Barthel Index at day 180 adjusted for baseline Barthel Index.
Time to first event of death, re-hospitalization or recurrent stroke	within 6 months after onset of symptoms (stroke)	To assess the time to first event of death, re-hospitalization or recurrent stroke.
Proportion of events of post stroke infections	within 7 days after onset of symptoms (stroke)	To assess the proportion of events of post stroke infections to day 7.
Proportion of events of post stroke infection or death	within 7 days after onset of symptoms (stroke)	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	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.
Stroke volume analysis	6 months after onset of symptoms (stroke)	To investigate the effect of an early PCT-guided antiinfective therapy on stroke volume.
Modified Rankin scale adjusted for baseline modified Rankin score	6 months after onset of symptoms (stroke)	To assess the modified Rankin scale at day 180 adjusted for baseline modified Rankin score.
Days alive and out of hospital	3 months after onset of symptoms (stroke)	To assess the days alive and out of hospital at day 90.
Proportion of patients receiving any antibiotic therapy	3 months after onset of symptoms (stroke)	To assess the proportion of patients receiving any antibiotic therapy for any duration within 90 days.
Modified Rankin scale (mRS) score 0-4 adjusted for baseline modified Rankin score	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.
Length of hospital stay	on discharge	To assess the length of hospital stay after acute stroke.
shift analysis of the mRS

Trial Locations

Locations (6)

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

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Klinikum Frankfurt (Oder) Neurologie; 🇩🇪 Frankfurt (Oder), Germany