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

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Charité University Medicine Berlin

Status

Completed

Conditions

Ischemic Stroke

Treatments

Device: Procalcitonin assay - B.R.A.H.M.S PCT ultrasensitive Kryptor

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01264549
STRAWINSKI

Details and patient eligibility

About

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.

Enrollment

230 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

230 participants in 2 patient groups

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

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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