PRophylaxis Against Early VENTilator-associated Infections in Acute Brain Injury

Launched by THE GEORGE INSTITUTE · Feb 9, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at whether giving a single dose of a common antibiotic can help prevent pneumonia in patients who have suffered a severe brain injury and need help breathing with a machine called a ventilator. When people have severe brain injuries, they might be unconscious and require a breathing tube. Sometimes, bacteria from the mouth can enter the lungs during this process, leading to infections. The goal of the trial is to see if giving the antibiotic early can improve the chances of recovery and survival for these patients.

To be eligible for the trial, participants must be at least 18 years old and require mechanical ventilation due to a specific type of severe brain injury. They should also be admitted to an Intensive Care Unit (ICU). However, patients who have had a breathing tube for more than 12 hours, have received antibiotics recently, or have certain medical conditions cannot participate. Those who join the study can expect to receive the antibiotic soon after their breathing tube is placed and will be monitored closely for any signs of pneumonia and their overall recovery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. ≥ 18 years of age
• • 2. Receiving invasive mechanical ventilation
• • 3. 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.
• • 4. Admitted to an ICU or is anticipated to be admitted to an ICU
• Exclusion Criteria:
• • 1. Endotracheal intubation was more than 12 hours ago
• • 2. Hospital admission was more than 72 hours ago
• • 3. Anticipated inability to deliver trial intervention within 90 minutes of randomisation
• • 4. Documented use of antibiotic therapy in the week prior to hospitalisation
• • 5. Currently receiving antibiotic therapy, or intention to prescribe antibiotic therapy, excluding cephazolin for peri-operative prophylaxis
• • 6. Any contraindication to receiving ceftriaxone
• • 7. Known or suspected pregnancy
• • 8. Death within 90 days is deemed inevitable due to the current illness or intercurrent medical conditions
• • 9. Previously enrolled in the PREVENT-NEURO trial.