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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Device: Procalcitonin assay - B.R.A.H.M.S PCT ultrasensitive Kryptor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCT guided arm<br> | Device: Procalcitonin assay - B.R.A.H.M.S PCT ultrasensitive Kryptor<br>* 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<br>* Other names: Procalcitonin;|
| No Intervention: Control<br>Standard treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months after onset of symptoms (stroke) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients receiving any antibiotic therapy | To assess the proportion of patients receiving any antibiotic therapy for any duration within 90 days. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 6 months after onset of symptoms (stroke) | 
| Length of hospital stay | To assess the length of hospital stay after acute stroke. | on discharge | 
| Hospital discharge disposition | To assess the disposition on hospital discharge. | on discharge | 
| shift analysis of the mRS |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic stroke, stroke-associated infections, biomarkers, PCT, immune and infection parameters