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PRophylaxis Against Early VENTilator-associated Infections in Acute Brain Injury

RecruitingPhase 3Ages 18 Years - anyAllThe George Institute
NCT06819592 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 th

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📋 Eligibility rules (as published)
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.
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What it tests

  • Ceftriaxone 2g diluted in >200ml 0.9%sodium chloride
  • Placebo comparator - no ceftriaxone
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Where

29 sites
Canberra Hospital
Canberra, Australia
Royal Prince Alfred Hospital
Camperdown, Australia
St. Vincent's Health Sydney
Darlinghurst, Australia
Dubbo Health Service
Dubbo, Australia
Nepean Hospital
Kingswood, Australia
St George Hospital
Kogarah, Australia
Liverpool Hospital
Liverpool, Australia
The George Institute
Randwick, Australia

…and 21 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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