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Ischemic StrokeSTRAWINSKINCT01264549

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

A study testing Procalcitonin assay - B.R.A.H.M.S PCT ultrasensitive Kryptor in people with Ischemic Stroke, run by Charite University, Berlin, Germany at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke
What is being tested?
Procalcitonin assay - B.R.A.H.M.S PCT ultrasensitive Kryptor
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
6 sitesin 2 countries
Study dates
Dec 2010to Oct 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Germany5 sites

  • Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)

    Berlin

  • Unfallkrankenhaus Berlin Neurologie

    Berlin

  • Vivantes Auguste Viktoria Klinikum Neurologie

    Berlin

  • Vivantes Neukölln Neurologie

    Berlin

  • Klinikum Frankfurt (Oder) Neurologie

    Frankfurt (Oder)

Other trials in Germany

Spain1 site

  • Hospital Vall d'Hebron

    Barcelona

Other trials in Spain

About this study

Official title: 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.

Conditions
Ischemic Stroke
Being tested
Procalcitonin assay - B.R.A.H.M.S PCT ultrasensitive Kryptor
Keywords
ischemic stroke, stroke-associated infections, biomarkers, PCT, immune and infection parameters
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Procalcitonin assay - B.R.A.H.M.S PCT ultrasensitive KryptorDevice

    Also called Procalcitonin

    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

Study groups in NCT01264549
Study groupRoleWhat they receive
PCT guided armExperimentalNot described
Receives: Device: Procalcitonin assay - B.R.A.H.M.S PCT ultrasensitive Kryptor
ControlNo interventionStandard treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months after onset of symptoms (stroke)

Secondary outcomes (15)

  1. Proportion of patients receiving any antibiotic therapy

    To assess the proportion of patients receiving any antibiotic therapy for any duration within 90 days.

    Measured: 3 months after onset of symptoms (stroke)

  2. Modified Rankin scale adjusted for baseline modified Rankin score

    To assess the Modified Rankin scale at day 90 adjusted for baseline modified Rankin score.

    Measured: 3 months after onset of symptoms (stroke)

  3. Barthel Index adjusted for baseline Barthel Index

    To assess the Barthel Index (BI 0-100) at day 90 adjusted for baseline Barthel Index.

    Measured: 3 months after onset of symptoms (stroke)

  4. 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.

    Measured: 6 months after onset of symptoms (stroke)

  5. Modified Rankin scale adjusted for baseline modified Rankin score

    To assess the modified Rankin scale at day 180 adjusted for baseline modified Rankin score.

    Measured: 6 months after onset of symptoms (stroke)

  6. Barthel Index adjusted for baseline Barthel Index

    To assess the Barthel Index at day 180 adjusted for baseline Barthel Index.

    Measured: 6 months after onset of symptoms (stroke)

  7. Days alive and out of hospital

    To assess the days alive and out of hospital at day 90.

    Measured: 3 months after onset of symptoms (stroke)

  8. 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.

    Measured: within 6 months after onset of symptoms (stroke)

  9. Proportion of events of post stroke infections

    To assess the proportion of events of post stroke infections to day 7.

    Measured: within 7 days after onset of symptoms (stroke)

  10. Proportion of events of post stroke infection or death

    To assess the proportion of events of post stroke infection or death to day 7.

    Measured: within 7 days after onset of symptoms (stroke)

  11. 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.

    Measured: within 7 days after onset of symptoms (stroke)

  12. Stroke volume analysis

    To investigate the effect of an early PCT-guided antiinfective therapy on stroke volume.

    Measured: 6 months after onset of symptoms (stroke)

  13. Length of hospital stay

    To assess the length of hospital stay after acute stroke.

    Measured: on discharge

  14. Hospital discharge disposition

    To assess the disposition on hospital discharge.

    Measured: on discharge

  15. shift analysis of the mRS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01264549
Sponsor's protocol ID
STRAWINSKI
Acronym
STRAWINSKI
Status last verified
Dec 2021
First submitted
21 Dec 2010
Last updated
4 Jan 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28484421

  • 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.

    PubMed 22925000

  • 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.

    PubMed 32098866

  • 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.

    PubMed 33280547

  • 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.

    PubMed 29202730

Questions about this trial

What is this clinical trial studying?

A study testing Procalcitonin assay - B.R.A.H.M.S PCT ultrasensitive Kryptor in people with Ischemic Stroke, run by Charite University, Berlin, Germany at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Rankin scale (mRS 0-6) score 0-4 adjusted for baseline modified Rankin score (time frame: 3 months after onset of symptoms (stroke)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01264549, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.

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