An interventional study of Procalcitonin assay - B.R.A.H.M.S PCT ultrasensitive Kryptor in Ischemic Stroke, sponsored by Charite University, Berlin, Germany. Completed at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-04.
Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 230 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Device: Procalcitonin assay - B.R.A.H.M.S PCT ultrasensitive Kryptor
Standard treatment
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
Also known as: Procalcitonin
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.
Time frame: 3 months after onset of symptoms (stroke)
Proportion of patients receiving any antibiotic therapy
To assess the proportion of patients receiving any antibiotic therapy for any duration within 90 days.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months after onset of symptoms (stroke)
Length of hospital stay
To assess the length of hospital stay after acute stroke.
Time frame: on discharge
Hospital discharge disposition
To assess the disposition on hospital discharge.
Time frame: on discharge
shift analysis of the mRS
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany