Actively Recruiting
PRophylaxis Against Early VENTilator-associated Infections in Acute Brain Injury
Led by The George Institute · Updated on 2026-02-19
3300
Participants Needed
9
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
PRophylaxis Against Early VENTilator-associated Infections in Acute Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Receiving invasive mechanical ventilation
- Mechanical ventilation due to acute brain injury such as 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 expected to be admitted to an ICU
You will not qualify if you...
- Endotracheal intubation occurred more than 12 hours ago
- Hospital admission was more than 72 hours ago
- Unable to receive trial intervention within 90 minutes of randomisation
- Used antibiotics in the week before hospital admission
- Currently receiving antibiotics or planning to receive antibiotics, except cephazolin for surgery
- Contraindication to ceftriaxone
- Known or suspected pregnancy
- Death within 90 days is expected due to current illness or other medical conditions
- Previously enrolled in this trial
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Nepean Hospital
Kingswood, New South Wales, Australia, 2747
Actively Recruiting
2
St George Hospital
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
3
The George Institute
Randwick, New South Wales, Australia, 2031
Not Yet Recruiting
4
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2000
Actively Recruiting
5
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4006
Actively Recruiting
6
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
7
The Alfred Hospital
Melbourne, Victoria, Australia
Not Yet Recruiting
8
Fiona Stanley Hospital
Perth, Western Australia, Australia, 6150
Not Yet Recruiting
9
Wellington Hospital
Wellington, New Zealand
Actively Recruiting
Research Team
T
Tina Schneider
CONTACT
D
Dorrilyn Rajbhandari
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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