Stroke Adverse Outcome is Associated With Nosocomial Infections: PCTus- Guided Antibacterial Therapy in Severe Ischemic Stroke Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 230
- Locations
- 6
- Primary Endpoint
- Modified Rankin scale (mRS 0-6) score 0-4 adjusted for baseline modified Rankin score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Control
Standard treatment
PCT guided arm
Intervention: Procalcitonin assay - B.R.A.H.M.S PCT ultrasensitive Kryptor (Device)
Outcomes
Primary Outcomes
Modified Rankin scale (mRS 0-6) score 0-4 adjusted for baseline modified Rankin score
Time Frame: 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 Outcomes
- Hospital discharge disposition(on discharge)
- Barthel Index adjusted for baseline Barthel Index(6 months after onset of symptoms (stroke))
- 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(within 7 days after onset of symptoms (stroke))
- Proportion of events of post stroke infection or death(within 7 days after onset of symptoms (stroke))
- Medium number of days with fever (≥ 37,5°C) per patient(within 7 days after onset of symptoms (stroke))
- Stroke volume analysis(6 months after onset of symptoms (stroke))
- Modified Rankin scale adjusted for baseline modified Rankin score(6 months after onset of symptoms (stroke))
- Days alive and out of hospital(3 months after onset of symptoms (stroke))
- Proportion of patients receiving any antibiotic therapy(3 months after onset of symptoms (stroke))
- Modified Rankin scale (mRS) score 0-4 adjusted for baseline modified Rankin score(6 months after onset of symptoms (stroke))
- Length of hospital stay(on discharge)
- shift analysis of the mRS
- Modified Rankin scale adjusted for baseline modified Rankin score(3 months after onset of symptoms (stroke))
- Barthel Index adjusted for baseline Barthel Index(3 months after onset of symptoms (stroke))
Investigators
Andreas Meisel
Prof. Dr. Andreas Meisel, Charité University, Berlin, Germany (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
Charite University, Berlin, Germany