New treatment option for All-cause Mortality
Official title PRophylaxis Against Early VENTilator-associated Infections in Acute Brain Injury
ClinicalTrials.gov ID: NCT06819592
What this study is testing
What is Ceftriaxone 2g diluted in >200ml 0.9%sodium chloride?
Ceftriaxone 2g diluted in >200ml 0.9%sodium chloride is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for all-cause mortality.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥ 18 years of age
- Receiving invasive mechanical ventilation
- The requirement for mechanical ventilation is because of an acute brain injury due to intracranial haemorrhage, ischaemic stroke, cerebral venous...
- Admitted to an ICU or is anticipated to be admitted to an ICU
You likely can't join if
- Endotracheal intubation was more than 12 hours ago
- Hospital admission was more than 72 hours ago
- Anticipated inability to deliver trial intervention within 90 minutes of randomisation
- Documented use of antibiotic therapy in the week prior to hospitalisation
- Currently receiving antibiotic therapy, or intention to prescribe antibiotic therapy, excluding cephazolin for peri-operative prophylaxis
- Any contraindication to receiving ceftriaxone
See the full eligibility criteria
- ≥ 18 years of age
- Receiving invasive mechanical ventilation
- 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...
- Admitted to an ICU or is anticipated to be admitted to an ICU
- Endotracheal intubation was more than 12 hours ago
- Hospital admission was more than 72 hours ago
- Anticipated inability to deliver trial intervention within 90 minutes of randomisation
- Documented use of antibiotic therapy in the week prior to hospitalisation
- Currently receiving antibiotic therapy, or intention to prescribe antibiotic therapy, excluding cephazolin for peri-operative prophylaxis
- Any contraindication to receiving ceftriaxone
- Known or suspected pregnancy
- Death within 90 days is deemed inevitable due to the current illness or intercurrent medical conditions
- Previously enrolled in the PREVENT-NEURO trial.
The study team makes the final eligibility decision.
Where it's taking place
- 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
- Melbourne, Victoria, Australia
- Perth, Western Australia, Australia
- Wellington, New Zealand
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.