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

Charite University, Berlin, Germany230 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

230

Conditions

Ischemic Stroke

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Klinikum Frankfurt (Oder) Neurologie

Frankfurt (Oder), Germany

Hospital Vall d'Hebron

Barcelona, Spain

Outcomes

Primary Outcomes

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

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.

Time frame: 3 months after onset of symptoms (stroke)

Secondary Outcomes

Proportion of patients receiving any antibiotic therapy

To assess the proportion of patients receiving any antibiotic therapy for any duration within 90 days.

Time frame: 3 months after onset of symptoms (stroke)

Modified Rankin scale adjusted for baseline modified Rankin score

To assess the Modified Rankin scale at day 90 adjusted for baseline modified Rankin score.

Time frame: 3 months after onset of symptoms (stroke)

Barthel Index adjusted for baseline Barthel Index

To assess the Barthel Index (BI 0-100) at day 90 adjusted for baseline Barthel Index.

Time frame: 3 months after onset of symptoms (stroke)

Modified Rankin scale (mRS) score 0-4 adjusted for baseline modified Rankin score

To assess the proportion of patients with a modified Rankin scale (mRS) score 0-4 at day 180 adjusted for baseline modified Rankin score.

Time frame: 6 months after onset of symptoms (stroke)

Modified Rankin scale adjusted for baseline modified Rankin score

To assess the modified Rankin scale at day 180 adjusted for baseline modified Rankin score.

Time frame: 6 months after onset of symptoms (stroke)

Barthel Index adjusted for baseline Barthel Index

To assess the Barthel Index at day 180 adjusted for baseline Barthel Index.

Time frame: 6 months after onset of symptoms (stroke)

Days alive and out of hospital

To assess the days alive and out of hospital at day 90.

Time frame: 3 months after onset of symptoms (stroke)

Time to first event of death, re-hospitalization or recurrent stroke

To assess the time to first event of death, re-hospitalization or recurrent stroke.

Time frame: within 6 months after onset of symptoms (stroke)

Proportion of events of post stroke infections

To assess the proportion of events of post stroke infections to day 7.

Time frame: within 7 days after onset of symptoms (stroke)

Proportion of events of post stroke infection or death

To assess the proportion of events of post stroke infection or death to day 7.

Time frame: within 7 days after onset of symptoms (stroke)

Medium number of days with fever (≥ 37,5°C) per patient

To assess the medium number of days with fever (≥ 37,5°C) per patient to day 7.

Time frame: within 7 days after onset of symptoms (stroke)

Stroke volume analysis

To investigate the effect of an early PCT-guided antiinfective therapy on stroke volume.

Time frame: 6 months after onset of symptoms (stroke)

Length of hospital stay

To assess the length of hospital stay after acute stroke.

Time frame: on discharge

Hospital discharge disposition

To assess the disposition on hospital discharge.

Time frame: on discharge

shift analysis of the mRS

Data from ClinicalTrials.gov

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