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Clinical trialNCT06819592RecruitingPhase 3Interventional

PRophylaxis Against Early VENTilator-associated Infections in Acute Brain Injury

SponsorThe George InstituteEnrollment3,300Acute Brain InjuryAll-cause MortalityDisability, IntellectualIntensive Care MedicineNeurological DisorderQuality of Life+1 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

9 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia
  • Nepean Hospital

    Kingswood, New South Wales, Australia

    Ian Seppelt, Prof
    Recruiting
  • St George Hospital

    Kogarah, New South Wales, Australia

    Manoj Saxena, DrMark Weeden, Dr
    Recruiting
  • the George Institute

    Randwick, New South Wales, Australia

    Not, yet, recruiting
  • Royal North Shore Hospital

    Sydney, New South Wales, Australia

    Anthony Delaney Delaney, Associate Professor
    Recruiting
  • Royal Brisbane and Women'S Hospital

    Herston, Queensland, Australia

    Elissa Milford, DrJeremy Cohen, A/Prof
    Recruiting
  • Princess Alexandra Hospital

    Woolloongabba, Queensland, Australia

    Kyle White, Dr
    Recruiting
  • the Alfred Hospital

    Melbourne, Victoria, Australia

    Andrew Udy
    Not, yet, recruiting
  • Fiona Stanley Hospital

    Perth, Western Australia, Australia

    Edward Litton, Prof
    Not, yet, recruiting
New Zealand
  • Wellington Hospital

    Wellington, New Zealand

    Paul Young
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

CeftriaxonePlacebo comparator - no ceftriaxone
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Oct 2025
Primary completion
31 Aug 2029
Completion
31 Dec 2029
Last update posted
19 Feb 2026
Registered enrollment
3,300
Registry id
NCT06819592

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.