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

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Procalcitonin assay - B.R.A.H.M.S PCT ultrasensitive Kryptor
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring ischemic stroke, stroke-associated infections, biomarkers, PCT, immune and infection parameters

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
  • Unfallkrankenhaus Berlin Neurologie
  • Vivantes Auguste Viktoria Klinikum Neurologie
  • Vivantes Neukölln Neurologie
  • Klinikum Frankfurt (Oder) Neurologie
  • Hospital Vall d'Hebron

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PCT guided arm

Control

Arm Description

Standard treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 21, 2010
Last Updated
December 15, 2021
Sponsor
Charite University, Berlin, Germany
Collaborators
Brahms AG, NeuroCure Clinical Research Center, Charite, Berlin
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1. Study Identification

Unique Protocol Identification Number
NCT01264549
Brief Title
Stroke Adverse Outcome is Associated With Nosocomial Infections: PCTus- Guided Antibacterial Therapy in Severe Ischemic Stroke Patients (STRAWINSKI)
Acronym
STRAWINSKI
Official Title
Stroke Adverse Outcome is Associated With Nosocomial Infections: PCTus- Guided Antibacterial Therapy in Severe Ischemic Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Brahms AG, NeuroCure Clinical Research Center, Charite, Berlin

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
ischemic stroke, stroke-associated infections, biomarkers, PCT, immune and infection parameters

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PCT guided arm
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard treatment
Intervention Type
Device
Intervention Name(s)
Procalcitonin assay - B.R.A.H.M.S PCT ultrasensitive Kryptor
Other Intervention Name(s)
Procalcitonin
Intervention Description
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
Primary Outcome Measure Information:
Title
Modified Rankin scale (mRS 0-6) score 0-4 adjusted for baseline modified Rankin score
Description
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)
Secondary Outcome Measure Information:
Title
Proportion of patients receiving any antibiotic therapy
Description
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)
Title
Modified Rankin scale adjusted for baseline modified Rankin score
Description
To assess the Modified Rankin scale at day 90 adjusted for baseline modified Rankin score.
Time Frame
3 months after onset of symptoms (stroke)
Title
Barthel Index adjusted for baseline Barthel Index
Description
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)
Title
Modified Rankin scale (mRS) score 0-4 adjusted for baseline modified Rankin score
Description
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)
Title
Modified Rankin scale adjusted for baseline modified Rankin score
Description
To assess the modified Rankin scale at day 180 adjusted for baseline modified Rankin score.
Time Frame
6 months after onset of symptoms (stroke)
Title
Barthel Index adjusted for baseline Barthel Index
Description
To assess the Barthel Index at day 180 adjusted for baseline Barthel Index.
Time Frame
6 months after onset of symptoms (stroke)
Title
Days alive and out of hospital
Description
To assess the days alive and out of hospital at day 90.
Time Frame
3 months after onset of symptoms (stroke)
Title
Time to first event of death, re-hospitalization or recurrent stroke
Description
To assess the time to first event of death, re-hospitalization or recurrent stroke.
Time Frame
within 6 months after onset of symptoms (stroke)
Title
Proportion of events of post stroke infections
Description
To assess the proportion of events of post stroke infections to day 7.
Time Frame
within 7 days after onset of symptoms (stroke)
Title
Proportion of events of post stroke infection or death
Description
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)
Title
Medium number of days with fever (≥ 37,5°C) per patient
Description
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)
Title
Stroke volume analysis
Description
To investigate the effect of an early PCT-guided antiinfective therapy on stroke volume.
Time Frame
6 months after onset of symptoms (stroke)
Title
Length of hospital stay
Description
To assess the length of hospital stay after acute stroke.
Time Frame
on discharge
Title
Hospital discharge disposition
Description
To assess the disposition on hospital discharge.
Time Frame
on discharge
Title
shift analysis of the mRS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Meisel, MD
Organizational Affiliation
Charité University Berlin (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefan Anker, MD PhD
Organizational Affiliation
Charité University Berlin (Dept of Cardiology)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
City
Berlin
Country
Germany
Facility Name
Unfallkrankenhaus Berlin Neurologie
City
Berlin
Country
Germany
Facility Name
Vivantes Auguste Viktoria Klinikum Neurologie
City
Berlin
Country
Germany
Facility Name
Vivantes Neukölln Neurologie
City
Berlin
Country
Germany
Facility Name
Klinikum Frankfurt (Oder) Neurologie
City
Frankfurt (Oder)
Country
Germany
Facility Name
Hospital Vall d'Hebron
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
28484421
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.
Results Reference
result
PubMed Identifier
22925000
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.
Results Reference
result
PubMed Identifier
32098866
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.
Results Reference
result
PubMed Identifier
33280547
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.
Results Reference
result
PubMed Identifier
29202730
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.
Results Reference
result

Learn more about this trial

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

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