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One-Dose antibiotic could slash ventilator pneumonia deaths in brain injury patients

NCT ID NCT06819592

Prevention Sponsor: The George Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This study tests whether giving a single dose of a common antibiotic soon after a breathing tube is placed can prevent lung infections and improve survival in ICU patients with severe brain injuries. Researchers will enroll 3,300 adults on ventilators due to stroke, trauma, or lack of oxygen. The goal is to see if early prevention of pneumonia leads to better recovery and lower death rates.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 3,300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

brain injury cerebral sinovenous thrombosis intellectual disability intracerebral hemorrhage ischemic stroke nervous system disorder perinatal asphyxia Respiratory Aspiration subarachnoid hemorrhage traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute brain injury All-cause mortality Disability, intellectual Intensive care medicine Neurological disorder Quality of life Ventilation, mechanical

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    29 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Austin Health

    NOT_YET_RECRUITING

    Heidelberg, Victoria, 3084, Australia

  • Bendigo Health

    NOT_YET_RECRUITING

    Bendigo, Victoria, 3550, Australia

  • Canberra Hospital

    NOT_YET_RECRUITING

    Canberra, Australian Capital Territory, 2605, Australia

  • Dubbo Health Service

    NOT_YET_RECRUITING

    Dubbo, New South Wales, 2830, Australia

  • Eastern Health Box Hill

    NOT_YET_RECRUITING

    Box Hill, Victoria, 3128, Australia

  • Fiona Stanley Hospital

    NOT_YET_RECRUITING

    Perth, Western Australia, 6150, Australia

  • Footscray Hospital Western Health

    NOT_YET_RECRUITING

    Footscray, Victoria, 3011, Australia

  • Gold Coast University Hospital

    NOT_YET_RECRUITING

    Gold Coast, Queensland, 4215, Australia

  • Liverpool Hospital

    NOT_YET_RECRUITING

    Liverpool, New South Wales, 2170, Australia

  • Nepean Hospital

    RECRUITING

    Kingswood, New South Wales, 2747, Australia

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • Royal Adelaide Hospital

    NOT_YET_RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Royal Brisbane and Women's Hospital

    RECRUITING

    Herston, Queensland, 4006, Australia

  • Royal Darwin Hospital

    NOT_YET_RECRUITING

    Tiwi, Northern Territory, 0810, Australia

  • Royal Hobart Hospital

    NOT_YET_RECRUITING

    Hobart, Tasmania, 7000, Australia

  • Royal North Shore Hospital

    RECRUITING

    Sydney, New South Wales, 2000, Australia

  • Royal Perth Hospital

    NOT_YET_RECRUITING

    Perth, Western Australia, 6000, Australia

  • Royal Prince Alfred Hospital

    NOT_YET_RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • Sir Charles Gairdner Hospital

    NOT_YET_RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • St George Hospital

    RECRUITING

    Kogarah, New South Wales, 2217, Australia

  • St Vincent's Hospital Melbourne

    NOT_YET_RECRUITING

    Fitzroy, Victoria, 3065, Australia

  • St. Vincent's Health Sydney

    NOT_YET_RECRUITING

    Darlinghurst, New South Wales, 2010, Australia

  • Sunshine Hospital - Western Health

    NOT_YET_RECRUITING

    Saint Albans, Victoria, 3021, Australia

  • The Alfred Hospital

    NOT_YET_RECRUITING

    Melbourne, Victoria, Australia

  • The George Institute

    NOT_YET_RECRUITING

    Randwick, New South Wales, 2031, Australia

  • Townsville University Hospital

    NOT_YET_RECRUITING

    Douglas, Queensland, 4814, Australia

  • University of Alberta

    NOT_YET_RECRUITING

    Edmonton, Alberta, T6G 2R3, Canada

  • Wellington Hospital

    RECRUITING

    Wellington, New Zealand

  • Westmead Hospital

    NOT_YET_RECRUITING

    Westmead, New South Wales, 2145, Australia

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