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

Ischemic Stroke Clinical Trial

— STRAWINSKI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01264549
• Other study ID #: STRAWINSKI
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Est. completion date: October 2014

Study information

• Verified date: December 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Cross Infection
• Infections
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
Germany	Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)	Berlin
Germany	Unfallkrankenhaus Berlin Neurologie	Berlin
Germany	Vivantes Auguste Viktoria Klinikum Neurologie	Berlin
Germany	Vivantes Neukölln Neurologie	Berlin
Germany	Klinikum Frankfurt (Oder) Neurologie	Frankfurt (Oder)
Spain	Hospital Vall d'Hebron	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Brahms AG, NeuroCure Clinical Research Center, Charite, Berlin

Countries where clinical trial is conducted

Germany,  Spain, 

References & Publications (5)

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 — View 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 — View 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. — View 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: — View 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 ischae — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months after onset of symptoms (stroke)
Secondary	Proportion of patients receiving any antibiotic therapy	To assess the proportion of patients receiving any antibiotic therapy for any duration within 90 days.	3 months after onset of symptoms (stroke)
Secondary	Modified Rankin scale adjusted for baseline modified Rankin score	To assess the Modified Rankin scale at day 90 adjusted for baseline modified Rankin score.	3 months after onset of symptoms (stroke)
Secondary	Barthel Index adjusted for baseline Barthel Index	To assess the Barthel Index (BI 0-100) at day 90 adjusted for baseline Barthel Index.	3 months after onset of symptoms (stroke)
Secondary	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.	6 months after onset of symptoms (stroke)
Secondary	Modified Rankin scale adjusted for baseline modified Rankin score	To assess the modified Rankin scale at day 180 adjusted for baseline modified Rankin score.	6 months after onset of symptoms (stroke)
Secondary	Barthel Index adjusted for baseline Barthel Index	To assess the Barthel Index at day 180 adjusted for baseline Barthel Index.	6 months after onset of symptoms (stroke)
Secondary	Days alive and out of hospital	To assess the days alive and out of hospital at day 90.	3 months after onset of symptoms (stroke)
Secondary	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.	within 6 months after onset of symptoms (stroke)
Secondary	Proportion of events of post stroke infections	To assess the proportion of events of post stroke infections to day 7.	within 7 days after onset of symptoms (stroke)
Secondary	Proportion of events of post stroke infection or death	To assess the proportion of events of post stroke infection or death to day 7.	within 7 days after onset of symptoms (stroke)
Secondary	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.	within 7 days after onset of symptoms (stroke)
Secondary	Stroke volume analysis	To investigate the effect of an early PCT-guided antiinfective therapy on stroke volume.	6 months after onset of symptoms (stroke)
Secondary	Length of hospital stay	To assess the length of hospital stay after acute stroke.	on discharge
Secondary	Hospital discharge disposition	To assess the disposition on hospital discharge.	on discharge
Secondary	shift analysis of the mRS