PRophylaxis Against Early VENTilator-associated Infections in Acute Brain Injury

Summary

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.

Conditions

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

Interventions

DRUG

Ceftriaxone 2g diluted in >200ml 0.9%sodium chloride

2 grams of Ceftriaxone diluted in \>200ml of 0.9%sodium chloride are administered intravenously once following randomisation

DRUG

Placebo comparator - no ceftriaxone

placebo: \>200ml 0.9% sodium chloride given as an intravenous infusion once after randomisation

Sponsors & Collaborators

• The George Institute

  lead OTHER

Principal Investigators

• Anthony Delaney, Prof · The George Institute

• Andrew Udy, Prof · The Alfred

• Edward Litton, Prof · Fiona Stanley Hospital

• Paul Young, Prof · Wellington Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-30

Primary Completion

2029-08-31

Completion

2029-12-31

Countries

• Australia
• New Zealand

Study Locations