NCT01264549

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

January 4, 2022

Status Verified

December 1, 2021

Enrollment Period

3.8 years

First QC Date

December 21, 2010

Last Update Submit

December 15, 2021

Conditions

Ischemic Stroke

Keywords

ischemic strokestroke-associated infectionsbiomarkersPCTimmune and infection parameters

Outcome Measures

Primary Outcomes (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.

    3 months after onset of symptoms (stroke)

Secondary Outcomes (15)

  • Proportion of patients receiving any antibiotic therapy

    3 months after onset of symptoms (stroke)

  • Modified Rankin scale adjusted for baseline modified Rankin score

    3 months after onset of symptoms (stroke)

  • Barthel Index 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

    6 months after onset of symptoms (stroke)

  • Modified Rankin scale adjusted for baseline modified Rankin score

    6 months after onset of symptoms (stroke)

  • +10 more secondary outcomes

Study Arms (2)

PCT guided arm

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

Control

NO INTERVENTION

Standard treatment

Interventions

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

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

Also known as: Procalcitonin
PCT guided arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

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

Berlin, Germany

Location

Unfallkrankenhaus Berlin Neurologie

Berlin, Germany

Location

Vivantes Auguste Viktoria Klinikum Neurologie

Berlin, Germany

Location

Vivantes Neukölln Neurologie

Berlin, Germany

Location

Klinikum Frankfurt (Oder) Neurologie

Frankfurt (Oder), Germany

Location

Hospital Vall d'Hebron

Barcelona, Spain

Location

Related Publications (5)

  • 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.

    PMID: 28484421RESULT

  • 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.

    PMID: 22925000RESULT

  • 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.

    PMID: 32098866RESULT

  • 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.

    PMID: 33280547RESULT

  • 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.

    PMID: 29202730RESULT

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Andreas Meisel, MD

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

    PRINCIPAL INVESTIGATOR

  • Stefan Anker, MD PhD

    Charité University Berlin (Dept of Cardiology)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Andreas Meisel, Charité University, Berlin, Germany (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)

Study Record Dates

First Submitted

December 21, 2010

First Posted

December 22, 2010

Study Start

December 1, 2010

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

January 4, 2022

Record last verified: 2021-12

Locations

DE(5)ES(1)