ANZICS CTG Endorsed Study
PREVENT-NEURO
PRophylaxis against Early VENTilator-associated infections in acute brain injury.
PRophylaxis against Early VENTilator-associated infections to reduce mortality in mechanically ventilated Intensive Care Unit (ICU) patients with acute brain injuries: a phase 3 randomised, double blind, parallel group, placebo-controlled two-side superiority trial.
Study Description
Multicentre, phase 3, randomised, double blind, parallel group, placebo-controlled two-side clinical trial.
PREVENT-NEURO is a multicentre, phase 3, randomised, double blind, parallel group randomised clinical trial of prophylactic antibiotic administration compared with placebo in patients with acute brain injury to the intensive care unit (ICU) in Australia and internationally. The requirement for mechanical ventilation is because of an acute brain injury that is due to intracranial haemorrhage, ischaemic stroke, cerebral venous sinus thrombosis, subarachnoid haemorrhage, suspected hypoxic ischaemic encephalopathy post cardiac arrest, or traumatic brain injury. The trial will involve patients with an acute brain injury who require mechanical ventilation, currently treated in the ICU. The intervention involves administration of one dose of 2 grams Ceftriaxone or 0.9% sodium chloride intravenously following randomisation. The primary outcome measures 90-day all-cause mortality. Planned sample size is a maximum of 3300 patients with sites in Australia and New Zealand and internationally in hospitals that admit adult patients with severe brain injury.
Management Committee
Anthony Delaney, Paul Young, Chris Andersen, Emily Fitzgerald, Naomi Hammond, Alisa Higgins, Serena Knowles, Edward Litton, John Myburgh, Dorrilyn Rajbhandari, Andrew Udy, Bala Venkatesh, Emily Fitzgerald
Administering Institution
The George Institute for Global Health
Sample Size
3300 patients
Funding
MRFF
Reference
CTG2425-02, NCT06819592
Contact
Dorrilyn Rajbhandari (email), Tina Schneider (email) or PREVENT_NEURO@georgeinstitute.org