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

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Procalcitonin assay - B.R.A.H.M.S PCT ultrasensitive Kryptor Device
    Other Names: Procalcitonin
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: PCT guided arm

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Modified Rankin scale (mRS 0-6) score 0-4 adjusted for baseline modified Rankin score 3 months after onset of symptoms (stroke) No
Secondary Proportion of patients receiving any antibiotic therapy 3 months after onset of symptoms (stroke) No
Secondary Modified Rankin scale adjusted for baseline modified Rankin score 3 months after onset of symptoms (stroke) No
Secondary Barthel Index adjusted for baseline Barthel Index 3 months after onset of symptoms (stroke) No
Secondary Modified Rankin scale (mRS) score 0-4 adjusted for baseline modified Rankin score 6 months after onset of symptoms (stroke) No
Secondary Days alive and out of hospital 3 months after onset of symptoms (stroke) No
Secondary Time to first event of death, re-hospitalization or recurrent stroke within 6 months after onset of symptoms (stroke) No
Secondary Proportion of events of post stroke infections within 7 days after onset of symptoms (stroke) No
Secondary Proportion of events of post stroke infection or death within 7 days after onset of symptoms (stroke) No
Secondary Medium number of days with fever (≥ 37,5°C) per patient within 7 days after onset of symptoms (stroke) No
Secondary Stroke volume analysis 6 months after onset of symptoms (stroke) No
Secondary Length of hospital stay on discharge No
Secondary Hospital discharge disposition on discharge No
Secondary shift analysis of the mRS No

Sponsors