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

December 15, 2021 updated by: Andreas Meisel, Charite University, Berlin, Germany

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, 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
      • Frankfurt (Oder), Germany
        • Klinikum Frankfurt (Oder) Neurologie
  • Spain
      • Barcelona, Spain
        • Hospital Vall d'Hebron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Standard treatment
Experimental: PCT guided arm
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
Other Names:
  • Procalcitonin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after onset of symptoms (stroke)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients receiving any antibiotic therapy
Time Frame: 3 months after onset of symptoms (stroke)
To assess the proportion of patients receiving any antibiotic therapy for any duration within 90 days.
3 months after onset of symptoms (stroke)
Modified Rankin scale adjusted for baseline modified Rankin score
Time Frame: 3 months after onset of symptoms (stroke)
To assess the Modified Rankin scale at day 90 adjusted for baseline modified Rankin score.
3 months after onset of symptoms (stroke)
Barthel Index adjusted for baseline Barthel Index
Time Frame: 3 months after onset of symptoms (stroke)
To assess the Barthel Index (BI 0-100) at day 90 adjusted for baseline Barthel Index.
3 months after onset of symptoms (stroke)
Modified Rankin scale (mRS) score 0-4 adjusted for baseline modified Rankin score
Time Frame: 6 months after onset of symptoms (stroke)
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)
Modified Rankin scale adjusted for baseline modified Rankin score
Time Frame: 6 months after onset of symptoms (stroke)
To assess the modified Rankin scale at day 180 adjusted for baseline modified Rankin score.
6 months after onset of symptoms (stroke)
Barthel Index adjusted for baseline Barthel Index
Time Frame: 6 months after onset of symptoms (stroke)
To assess the Barthel Index at day 180 adjusted for baseline Barthel Index.
6 months after onset of symptoms (stroke)
Days alive and out of hospital
Time Frame: 3 months after onset of symptoms (stroke)
To assess the days alive and out of hospital at day 90.
3 months after onset of symptoms (stroke)
Time to first event of death, re-hospitalization or recurrent stroke
Time Frame: within 6 months after onset of symptoms (stroke)
To assess the 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
Time Frame: within 7 days after onset of symptoms (stroke)
To assess the proportion of events of post stroke infections to day 7.
within 7 days after onset of symptoms (stroke)
Proportion of events of post stroke infection or death
Time Frame: within 7 days after onset of symptoms (stroke)
To assess the proportion of events of post stroke infection or death to day 7.
within 7 days after onset of symptoms (stroke)
Medium number of days with fever (≥ 37,5°C) per patient
Time Frame: within 7 days after onset of symptoms (stroke)
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)
Stroke volume analysis
Time Frame: 6 months after onset of symptoms (stroke)
To investigate the effect of an early PCT-guided antiinfective therapy on stroke volume.
6 months after onset of symptoms (stroke)
Length of hospital stay
Time Frame: on discharge
To assess the length of hospital stay after acute stroke.
on discharge
Hospital discharge disposition
Time Frame: on discharge
To assess the disposition on hospital discharge.
on discharge
shift analysis of the mRS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

NeuroCure Clinical Research Center, Charite, Berlin
Brahms AG

Investigators

  • Principal Investigator: Stefan Anker, MD PhD, Charité University Berlin (Dept of Cardiology)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

December 21, 2010

First Submitted That Met QC Criteria

December 21, 2010

First Posted (Estimate)

December 22, 2010

Study Record Updates

Last Update Posted (Actual)

January 4, 2022

Last Update Submitted That Met QC Criteria

December 15, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STRAWINSKI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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