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

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.