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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
230

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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'hebrón

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charite University, Berlin, Germany

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
NeuroCure Clinical Research Center, Charite, Berlin
Brahms AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STRAWINSKI

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