Clinical trial NCT01264549: Stroke Adverse Outcome is Associated With Nosocomial Infections: PCTus- Guided Antibacterial Therapy in Severe Ischemic Stroke Patients (STRAWINSKI)
Official title: Stroke Adverse Outcome is Associated With Nosocomial Infections: PCTus- Guided Antibacterial Therapy in Severe Ischemic Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Keywords: ischemic stroke
stroke-associated infections
biomarkers
PCT
immune and infection parameters
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Brahms AG
name: NeuroCure Clinical Research Center, Charite, Berlin
First posted: 2010-12-22
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Modified Rankin scale (mRS 0-6) score 0-4 adjusted for baseline modified Rankin score
timeFrame: 3 months after onset of symptoms (stroke)
Secondary outcomes:
measure: Proportion of patients receiving any antibiotic therapy
timeFrame: 3 months after onset of symptoms (stroke)
measure: Modified Rankin scale adjusted for baseline modified Rankin score
timeFrame: 3 months after onset of symptoms (stroke)
measure: Barthel Index adjusted for baseline Barthel Index
timeFrame: 3 months after onset of symptoms (stroke)
measure: Modified Rankin scale (mRS) score 0-4 adjusted for baseline modified Rankin score
timeFrame: 6 months after onset of symptoms (stroke)
measure: Modified Rankin scale adjusted for baseline modified Rankin score
timeFrame: 6 months after onset of symptoms (stroke)
measure: Barthel Index adjusted for baseline Barthel Index
timeFrame: 6 months after onset of symptoms (stroke)
measure: Days alive and out of hospital
timeFrame: 3 months after onset of symptoms (stroke)
measure: Time to first event of death, re-hospitalization or recurrent stroke
timeFrame: within 6 months after onset of symptoms (stroke)
measure: Proportion of events of post stroke infections
timeFrame: within 7 days after onset of symptoms (stroke)
measure: Proportion of events of post stroke infection or death
timeFrame: within 7 days after onset of symptoms (stroke)
measure: Medium number of days with fever (≥ 37,5°C) per patient
timeFrame: within 7 days after onset of symptoms (stroke)
measure: Stroke volume analysis
timeFrame: 6 months after onset of symptoms (stroke)
measure: Length of hospital stay
timeFrame: on discharge
measure: Hospital discharge disposition
timeFrame: on discharge
measure: shift analysis of the mRS
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin Neurologie
city: Berlin
country: Germany
facility: Vivantes Auguste Viktoria Klinikum Neurologie
city: Berlin
country: Germany
facility: Vivantes Neukölln Neurologie
city: Frankfurt (Oder)
country: Germany
facility: Klinikum Frankfurt (Oder) Neurologie
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
Study officials:
affiliation: Charité University Berlin (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
name: Andreas Meisel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charité University Berlin (Dept of Cardiology)
name: Stefan Anker, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. The Randomized Controlled STRAWINSKI Trial: Procalcitonin-Guided Antibiotic Therapy after Stroke. Front Neurol. 2017 Apr 24;8:153. doi: 10.3389/fneur.2017.00153. eCollection 2017.
citation: Ulm L, Ohlraun S, Harms H, Hoffmann S, Klehmet J, Ebmeyer S, Hartmann O, Meisel C, Anker SD, Meisel A. STRoke Adverse outcome is associated WIth NoSocomial Infections (STRAWINSKI): procalcitonin ultrasensitive-guided antibacterial therapy in severe ischaemic stroke patients - rationale and protocol for a randomized controlled trial. Int J Stroke. 2013 Oct;8(7):598-603. doi: 10.1111/j.1747-4949.2012.00858.x. Epub 2012 Aug 28.
citation: Hotter B, Hoffmann S, Ulm L, Montaner J, Bustamante A, Meisel C, Meisel A. Inflammatory and stress markers predicting pneumonia, outcome, and etiology in patients with stroke: Biomarkers for predicting pneumonia, functional outcome, and death after stroke. Neurol Neuroimmunol Neuroinflamm. 2020 Feb 25;7(3):e692. doi: 10.1212/NXI.0000000000000692. Print 2020 May.
citation: Hotter B, Hoffmann S, Ulm L, Meisel C, Bustamante A, Montaner J, Katan M, Smith CJ, Meisel A. External Validation of Five Scores to Predict Stroke-Associated Pneumonia and the Role of Selected Blood Biomarkers. Stroke. 2021 Jan;52(1):325-330. doi: 10.1161/STROKEAHA.120.031884. Epub 2020 Dec 7.
citation: Hotter B, Ulm L, Hoffmann S, Katan M, Montaner J, Bustamante A, Meisel A. Selection bias in clinical stroke trials depending on ability to consent. BMC Neurol. 2017 Dec 4;17(1):206. doi: 10.1186/s12883-017-0989-9.