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ISRCTN
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ISRCTN66140176
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ClinicalTrials.gov identifier
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Public title
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Preventive Antibiotics in Stroke Study
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Scientific title
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Preventive ceftriaxone to improve functional health in patients with stroke by preventing infection: a multicentre prospective randomised controlled trial
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Acronym
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PASS
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Serial number at source
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N/A
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Study hypothesis
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We hypothesise that preventive use of the antibiotic ceftriaxone improves functional health outcome in patients with stroke by preventing infection.
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Ethics approval
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METC of the Academic Medical Center in Amsterdam pending approval as of 17/03/2010
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Study design
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Multicentre prospective randomised open-label blinded endpoint trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Stroke, infection
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Participants - inclusion criteria
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1. Aged greater than or equal to 18 years, either sex
2. Stroke (ischaemic and haemorrhagic)
3. Any measurable neurological deficit defined as National Institutes of Health Stroke Scale (NIHSS) greater than 1
4. Stroke onset less than 24 hours
5. Admission
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Participants - exclusion criteria
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1. Symptoms or signs of infection on admission requiring antibiotic therapy
2. Use of antibiotics less than 24 hours before admission
3. Pregnancy
4. Hypersensitivity for cephalosporin
5. Previous anaphylaxis for penicillin or penicillin-derivates
6. Subarachnoid haemorrhage
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Anticipated start date
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01/05/2010
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Anticipated end date
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01/05/2014
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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3200
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Interventions
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Our intervention group will be treated with optimal medical care and ceftriaxone 2000 mg, intravenously, 1 time daily, for 4 days. The control group will receive the optimal medical care without ceftriaxone. The total duration of follow-up is 3 months; the primary outcome will then be assessed in a structured interview by telephone.
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Primary outcome measure(s)
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Functional health at 3-month follow-up, as assessed by the modified Rankin scale (mRS) dichotomised as a favorable outcome (mRS 0 - 2) or an unfavorable outcome (mRS 3 - 6)
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Secondary outcome measure(s)
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1. Death rate at discharge and 3 months
2. Infection rate during hospital admission
3. Length of hospital admission
4. Volume of post-stroke care
5. Use of antibiotics during the 3 months follow-up
6. Functional health using the full ordinal scoring range of the mRS
7. Quality adjusted life years (QALYs)
8. Costs
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Sources of funding
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1. Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 171002302)
2. Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands) (ref: CD 300006)
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Trial website
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Publications
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Contact name
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Dr
Diederik
van de Beek
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Address
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Department of Neurology
Academic Medical Centre
Meibergdreef 9
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City/town
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Amsterdam
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Zip/Postcode
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1100 DE
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Country
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Netherlands
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Sponsor
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Academic Medical Centre (AMC) (Netherlands)
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Address
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Department of Neurology
Meibergdreef 9
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City/town
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Amsterdam
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Zip/Postcode
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1105AZ
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Country
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Netherlands
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Sponsor website:
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http://www.amc.uva.nl/
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Date applied
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17/03/2010
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Last edited
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06/04/2010
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Date ISRCTN assigned
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06/04/2010
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