NCT06819592 PRophylaxis Against Early VENTilator-associated Infections in Acute Brain Injury
| NCT ID | NCT06819592 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | The George Institute |
| Condition | All-cause Mortality |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,300 participants |
| Start Date | 2025-10-30 |
| Primary Completion | 2029-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 3,300 participants in total. It began in 2025-10-30 with a primary completion date of 2029-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Anthony Delaney, Prof
STUDY CHAIR
The George Institute
Frequently Asked Questions
Who can join the NCT06819592 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying All-cause Mortality. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06819592 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 3,300 participants.
Is NCT06819592 currently recruiting?
Yes, NCT06819592 is actively recruiting participants. Contact the research team at tschneider@georgeinstitute.org.au for enrollment information.
Where is the NCT06819592 trial being conducted?
This trial is being conducted at Kingswood, Australia, Kogarah, Australia, Randwick, Australia, Sydney, Australia and 5 additional locations.
Who is sponsoring the NCT06819592 clinical trial?
NCT06819592 is sponsored by The George Institute. The principal investigator is Anthony Delaney, Prof at The George Institute. The trial plans to enroll 3,300 participants.