PRophylaxis Against Early VENTilator-associated Infections in Acute Brain Injury

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: All-cause Mortality, Quality of Life, Disability, Intellectual, Neurological Disorder, Acute Brain Injury, Ventilation, Mechanical, Intensive Care Medicine

In brief

This research is about whether treatment with a commonly used antibiotic can prevent infections in airway and lungs and improves the chance of surviving, if it is given soon after patients commence mechanical ventilation when they have been admitted to hospital with an acute severe brain injury. An acute severe brain injury can occur as a result of a stroke, a traumatic injury or due to lack of oxygen to the brain that happens as a result of a cardiac arrest. Patients who are unconscious after an acute severe brain injury often need assistance to breath adequately, and this assistance is given by a breathing tube, connected to a mechanical ventilator. This treatment is an emergency medical treatment. The breathing tube is inserted into the patients' airway by either their mouth or neck. For patients who need assistance with their breathing from a mechanical ventilator, infections in the airways and lungs, known as pneumonia, are a common complication. Everyone naturally has bacteria in their mouth, esophagus and stomach. Clinicians think that during the process of inserting the breathing tube, small amounts of these bacteria can be introduced into the airways and lung when people are unconscious following an acute severe brain injury, or during the process of placing the breathing tube into the airways. These bacteria are now in a place they aren't meant to be and can cause an infections in the airways and lungs known as pneumonia. The purpose of this research is to see if giving one dose of a common antibiotic can prevent patients developing pneumonia, which is associated with having a breathing tube inserted and being on a ventilator, improving the chance of recovery following the acute severe brain injury and ultimately improving the chance of surviving. When patients have a known infection, current guidelines are to treat them with antibiotics. Antibiotics work to kill the bacteria causing the infection. When a patient has an infection in their lungs, they often need to stay on the mechanical ventilator for longer. While current practice is to give patients with a proven infection in their airways and lungs (pneumonia) antibiotics, it is unknown if giving an antibiotic to patients to prevent these infections before they show signs of pneumonia may lead to better outcomes.

Key facts

Study ID

NCT06819592

Run by

The George Institute

People needed

3300

Starts

2025-10-30

Expected to finish

2029-12-01

Last updated by the study team

2026-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years of age
• Receiving invasive mechanical ventilation
• The requirement for mechanical ventilation is because of an acute brain injury due to intracranial haemorrhage, ischaemic stroke, cerebral venous sinus thrombosis, subarachnoid haemorrhage, suspected hypoxic ischaemic encephalopathy post cardiac arrest, or traumatic brain injury.
• Admitted to an ICU or is anticipated to be admitted to an ICU

You may not qualify if…

• Endotracheal intubation was more than 12 hours ago
• Hospital admission was more than 72 hours ago
• Anticipated inability to deliver trial intervention within 90 minutes of randomisation
• Documented use of antibiotic therapy in the week prior to hospitalisation
• Currently receiving antibiotic therapy, or intention to prescribe antibiotic therapy, excluding cephazolin for peri-operative prophylaxis
• Any contraindication to receiving ceftriaxone
• Known or suspected pregnancy
• Death within 90 days is deemed inevitable due to the current illness or intercurrent medical conditions
• Previously enrolled in the PREVENT-NEURO trial.

Where it is running

• Wellington Hospital — Wellington, New Zealand (enrolling)
• St George Hospital — Kogarah, New South Wales, Australia (enrolling)
• Royal Brisbane and Women's Hospital — Herston, Queensland, Australia (enrolling)
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (enrolling)
• Nepean Hospital — Kingswood, New South Wales, Australia (enrolling)
• Royal North Shore Hospital — Sydney, New South Wales, Australia (enrolling)
• The George Institute — Randwick, New South Wales, Australia
• Fiona Stanley Hospital — Perth, Western Australia, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia

Full record on ClinicalTrials.gov

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