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

NCT ID: NCT01264549

Last Updated: 2022-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2014-10-31

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PCT guided arm

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Control

Standard treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Procalcitonin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brahms AG

INDUSTRY

Sponsor Role: collaborator

NeuroCure Clinical Research Center, Charite, Berlin

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Andreas Meisel

Prof. Dr. Andreas Meisel, Charité University, Berlin, Germany (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas Meisel, MD

Role: PRINCIPAL_INVESTIGATOR

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

Stefan Anker, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Charité University Berlin (Dept of Cardiology)

Locations

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

Berlin, , Germany

Klinikum Frankfurt (Oder) Neurologie

Frankfurt (Oder), , Germany

Hospital Vall d'Hebron

Barcelona, , Spain

Countries

Germany; Spain

References

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.

Reference Type: RESULT

PMID: 28484421 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22925000 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32098866 (View on PubMed)

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.

Reference Type: RESULT

PMID: 33280547 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29202730 (View on PubMed)

Other Identifiers

STRAWINSKI

Identifier Type: -

Identifier Source: org_study_id