Preventing early ventilator infections after severe brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with recent severe brain injury who require invasive mechanical ventilation are randomly assigned to receive either a single 2 g dose of ceftriaxone or placebo shortly after intubation. The trial compares rates of early ventilator-associated lower respiratory tract infection, death, and functional outcomes between groups. Patients treated at participating ICUs in New South Wales are enrolled within a strict time window (intubation within 12 hours, hospital admission within 72 hours). Standard ICU care is continued for all patients while outcomes are followed for mortality and quality of life measures.

Why it matters

Who can join: the full rules

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.

Where it's running

• Nepean Hospital
  Kingswood, New South Wales, Australia Recruiting
• St George Hospital
  Kogarah, New South Wales, Australia Recruiting
• Royal North Shore Hospital
  Sydney, New South Wales, Australia Recruiting
• Royal Brisbane and Women's Hospital
  Herston, Queensland, Australia Recruiting
• Princess Alexandra Hospital
  Woolloongabba, Queensland, Australia Recruiting
• Wellington Hospital
  Wellington, New Zealand Recruiting

Study contacts

• Principal investigator: Andrew Udy, Prof — The Alfred
• Study coordinator: Tina Schneider
• Email: tschneider@georgeinstitute.org.au
• Phone: +61 02 8052 4562

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Gut microbes and blood signals in sepsis-related liver and kidney injury

  This study tests whether gut microbes and blood markers differ in adults with sepsis who develop liver or kidney injury, compared with healthy volunteers.

  Recruiting at 6 sites First Affiliated Hospital of Zhejiang University · Hangzhou, Zhejiang and 5 other locations · NCT07735182

• Brain monitoring during ventilator therapy in critically ill patients

  This study tests how lung-directed ventilator adjustments affect brain activity and blood flow in adults with acute brain injury who need mechanical ventilation.

  Recruiting Shengli Oilfield Hospital · Dongying, Shandong · NCT07716787

• How environment and biology together predict health, aging, and death

  Researchers are following adults to see how living conditions and biology together relate to aging and life expectancy, by linking personal health data with environmental and social information over time.

  Recruiting Longevity Metrics, Inc. · Boulder, Colorado · NCT07646782

• Neutral fluid balance in adults with traumatic brain injury (LIMIT-TBI)

  This study tests whether keeping daily fluid balance around zero (within 500 mL) for the first 5 days in the ICU is feasible and safe for adults with traumatic brain injury.

  Recruiting at 3 sites Phase 2 Erasme University Hospital · Brussels and 2 other locations · NCT07625995

• Portable MRI for kids with hypoxic brain injury

  This study tests whether a bedside, low-field portable MRI can accurately detect hypoxic-ischemic brain injuries in children compared with standard imaging.

  Recruiting Children's Mercy Hospital Kansas City · Kansas City, Missouri · NCT07577336

• 100-Year Human Aging and Longevity Tracking Program

  This project will follow adults over their lifetimes to see if repeated health tests can predict lifespan, causes of death, serious disease, and loss of function.

  Recruiting Longevity Metrics, Inc. · Boulder, Colorado · NCT07563777

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.