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Table 1 All items from the World Health Organization Trial Registration Data Set (SPIRIT checklist, item 2b)

From: Update on the Preventive Antibiotics in Stroke Study (PASS): a randomised controlled phase 3 clinical trial

Data category Information
Primary registry and trial identifying number Current controlled trials; http://www.controlled-trials.com; ISRCTN66140176
Date of registration in primary registry 6 April 2010
Secondary identifying numbers -
Source(s) of monetary or material support 1. Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 171002302) 2. Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands) (ref: CD 300006)
Primary sponsor Academic Medical Centre (AMC) (Netherlands)
Secondary sponsor(s) -
Contact for public queries Paul J Nederkoorn; P.J.Nederkoorn@amc.uva.nl
Contact for scientific queries Paul J Nederkoorn, Department of Neurology, Academic Medical Centre, PO box 22660, 1100 DD Amsterdam, The Netherlands.
Public title Preventive Antibiotics in Stroke Study
Scientific title Preventive ceftriaxone to improve functional health in patients with stroke by preventing infection: a multicentre prospective randomised controlled trial
Countries of recruitment The Netherlands
Health condition(s) or problem(s) studied Stroke, infection
Intervention(s) Optimal medical care and ceftriaxone 2,000 mg intravenously, once daily, for four days, versus optimal medical care without ceftriaxone.
Key inclusion and exclusion criteria Inclusion criteria: aged greater than or equal to 18 years, either sex; stroke (ischaemic and haemorrhagic); any measurable neurological deficit defined as National Institutes of Health Stroke Scale (NIHSS) greater than 1; stroke onset less than 24 hours; admission.
  Exclusion criteria: symptoms or signs of infection on admission requiring antibiotic therapy; use of antibiotics less than 24 hours before admission; pregnancy; hypersensitivity for cephalosporin; previous anaphylaxis for penicillin or derivates; subarachnoid haemorrhage; death seems imminent.
Study type Multicentre prospective randomised open-label blinded end point trial
Date of first enrolment 4 July 2010
Target sample size 2,550
Recruitment status Recruiting
Primary outcome(s) Functional health at three-month follow-up, as assessed by the modified Rankin Scale (mRS)
Key secondary outcomes Death rate at discharge and three months, infection rate during hospital admission; length of hospital admission; volume of post-stroke care; use of antibiotics during hospital stay; Quality adjusted life years (QALYs); costs.