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

Conditions

Ischemic Stroke

Keywords

ischemic stroke, stroke-associated infections, biomarkers, PCT, immune and infection parameters

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.

Sperber PS, Hotter B, Endres M, Prüss H, Meisel A.

2025-12-09

10.3390/diagnostics15243132

External Validation of Five Scores to Predict Stroke-Associated Pneumonia and the Role of Selected Blood Biomarkers

Benjamin Hotter, Sarah Hoffmann, Lena Ulm, Christian Meisel, Alejandro Bustamante et al. (9 authors)

Stroke2020-12-0737 citations

10.1161/strokeaha.120.031884

Inflammatory and stress markers predicting pneumonia, outcome, and etiology in patients with stroke

Benjamin Hotter, Sarah Hoffmann, Lena Ulm, Joan Montaner, Alejandro Bustamante et al. (7 authors)

Neurology Neuroimmunology & Neuroinflammation2020-02-2642 citations

10.1212/nxi.0000000000000692

Selection bias in clinical stroke trials depending on ability to consent.

Hotter B, Ulm L, Hoffmann S, Katan M, Montaner J, Bustamante A, Meisel A.

2017-12-0418 citations

10.1186/s12883-017-0989-9

The Randomized Controlled STRAWINSKI Trial: Procalcitonin-Guided Antibiotic Therapy after Stroke.

Ulm L, Hoffmann S, Nabavi D, Hermans M, Mackert BM, Hamilton F, Schmehl I, Jungehuelsing GJ, Montaner J, Bustamante A, Katan M, Hartmann A, Ebmeyer S, Dinter C, Wiemer JC, Hertel S, Meisel C, Anker SD, Meisel A.

2017-04-2436 citations

10.3389/fneur.2017.00153

Interventions

DEVICEProcalcitonin 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Modified Rankin scale adjusted for baseline modified Rankin score	3 months after onset of symptoms (stroke)	To assess the Modified Rankin scale at day 90 adjusted for baseline modified Rankin score.
Barthel Index adjusted for baseline Barthel Index	3 months after onset of symptoms (stroke)	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	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.
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.
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 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.
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.
Length of hospital stay	on discharge	To assess the length of hospital stay after acute stroke.
Hospital discharge disposition	on discharge	To assess the disposition on hospital discharge.
shift analysis of the mRS	—	—
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.

Countries

Germany, Spain

Outcome results

None listed