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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Brahms AG
Information provided by (Responsible Party):
Andreas Meisel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01264549
First received: December 21, 2010
Last updated: May 28, 2014
Last verified: May 2014

December 21, 2010
May 28, 2014
December 2010
July 2014   (final data collection date for 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) ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01264549 on ClinicalTrials.gov Archive Site
  • Proportion of patients receiving any antibiotic therapy [ Time Frame: 3 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To assess the Modified Rankin scale at day 90 adjusted for baseline modified Rankin score.
  • Barthel Index adjusted for baseline Barthel Index [ Time Frame: 3 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To assess the modified Rankin scale at day 180 adjusted for baseline modified Rankin score.
  • Barthel Index adjusted for baseline Barthel Index [ Time Frame: 6 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To assess the Barthel Index at day 180 adjusted for baseline Barthel Index.
  • Days alive and out of hospital [ Time Frame: 3 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To assess the days alive and out of hospital at day 90.
  • Time to first event of death, re-hospitalization or recurrent stroke [ Time Frame: within 6 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To assess the time to first event of death, re-hospitalization or recurrent stroke.
  • Proportion of events of post stroke infections [ Time Frame: within 7 days after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To assess the proportion of events of post stroke infections to day 7.
  • Proportion of events of post stroke infection or death [ Time Frame: within 7 days after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    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 [ Time Frame: within 7 days after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To assess the medium number of days with fever (≥ 37,5°C) per patient to day 7.
  • Stroke volume analysis [ Time Frame: 6 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To investigate the effect of an early PCT-guided antiinfective therapy on stroke volume.
  • Length of hospital stay [ Time Frame: on discharge ] [ Designated as safety issue: No ]
    To assess the length of hospital stay after acute stroke.
  • Hospital discharge disposition [ Time Frame: on discharge ] [ Designated as safety issue: No ]
    To assess the disposition on hospital discharge.
  • shift analysis of the mRS [ Designated as safety issue: No ]
  • Proportion of patients receiving any antibiotic therapy [ Time Frame: 3 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To assess the Modified Rankin scale at day 90 adjusted for baseline modified Rankin score.
  • Barthel Index adjusted for baseline Barthel Index [ Time Frame: 3 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To assess the modified Rankin scale at day 180 adjusted for baseline modified Rankin score.
  • Barthel Index adjusted for baseline Barthel Index [ Time Frame: 6 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To assess the Barthel Index at day 180 adjusted for baseline Barthel Index.
  • Days alive and out of hospital [ Time Frame: 3 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To assess the days alive and out of hospital at day 90.
  • Time to first event of death, re-hospitalization or recurrent stroke [ Time Frame: within 6 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To assess the time to first event of death, re-hospitalization or recurrent stroke.
  • Proportion of events of post stroke infections [ Time Frame: within 7 days after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To assess the proportion of events of post stroke infections to day 7.
  • Proportion of events of post stroke infection or death [ Time Frame: within 7 days after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    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 [ Time Frame: within 7 days after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To assess the medium number of days with fever (≥ 37,5°C) per patient to day 7.
  • Stroke volume analysis [ Time Frame: 6 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To investigate the effect of an early PCT-guided antiinfective therapy on stroke volume.
Not Provided
Not Provided
 
Stroke Adverse Outcome is Associated With Nosocomial Infections: PCTus- Guided Antibacterial Therapy in Severe Ischemic Stroke Patients (STRAWINSKI)
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Ischemic Stroke
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 Name: Procalcitonin
  • Experimental: PCT guided arm
    Intervention: Device: Procalcitonin assay - B.R.A.H.M.S PCT ultrasensitive Kryptor
  • No Intervention: Control
    Standard treatment
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
230
October 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Spain
 
NCT01264549
STRAWINSKI
Yes
Andreas Meisel, Charite University, Berlin, Germany
Charite University, Berlin, Germany
Brahms AG
Principal Investigator: 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)
Charite University, Berlin, Germany
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP