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. |