PRophylaxis Against Early VENTilator-associated Infections in Acute Brain Injury
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 i
| Condition(s) | All-cause Mortality, Quality of Life, Disability, Intellectual, Neurological Disorder, Acute Brain Injury, Ventilation, Mechanical, Intensive Care Medicine |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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. Fo |
| Who can participate | 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 antibi |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | The George Institute |
| Locations | Kingswood, New South Wales, Australia; Kogarah, New South Wales, Australia; Randwick, New South Wales, Australia; Sydney, New South Wales, Australia; Herston, Queensland, Australia; Woolloongabba, Queensland, Australia (+3 more sites) |
| Start date | 2025-10-30 |
| NCT ID | NCT06819592 |
| Official listing | https://clinicaltrials.gov/study/NCT06819592 |