Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06819592




Registration number
NCT06819592
Ethics application status
Date submitted
2/01/2025
Date registered
11/02/2025
Date last updated
11/02/2025

Titles & IDs
Public title
PRophylaxis Against Early VENTilator-associated Infections in Acute Brain Injury
Scientific title
PRophylaxis Against Early VENTilator-associated Infections to Reduce Mortality in Mechanically Ventilated Intensive Care Unit (ICU) Patients With Acute Brain Injuries: a Phase 3 Randomised, Double Blind, Parallel Group, Placebo-controlled Two-side Superiority Trial
Secondary ID [1] 0 0
GNT 2032610.
Secondary ID [2] 0 0
TGI-CCP-7738368-63876
Universal Trial Number (UTN)
Trial acronym
PREVENT-NEURO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
All-cause Mortality 0 0
Quality of Life 0 0
Disability, Intellectual 0 0
Neurological Disorder 0 0
Acute Brain Injury 0 0
Ventilation, Mechanical 0 0
Intensive Care Medicine 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Learning disabilities
Mental Health 0 0 0 0
Other mental health disorders
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ceftriaxone 2g diluted in >200ml 0.9%sodium chloride
Treatment: Drugs - Placebo comparator - no ceftriaxone

Active comparator: Ceftriaxone injection - 2 grams Ceftriaxone must be diluted in a minimum volume of 200 mL of 0.9% sodium chloride.

Placebo comparator: Placebo - In form of a minimum volume of 200 mL of 0.9% sodium chloride.


Treatment: Drugs: Ceftriaxone 2g diluted in >200ml 0.9%sodium chloride
2 grams of Ceftriaxone diluted in \>200ml of 0.9%sodium chloride are administered intravenously once following randomisation

Treatment: Drugs: Placebo comparator - no ceftriaxone
placebo: \>200ml 0.9% sodium chloride given as an intravenous infusion once after randomisation
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All cause mortality
Timepoint [1] 0 0
90 days
Secondary outcome [1] 0 0
Functional outcome
Timepoint [1] 0 0
Measured 180 days post randomisation

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/01/2029
Actual
Sample size
Target
3100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
Recruitment hospital [3] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [4] 0 0
The George Institute - Sydney
Recruitment hospital [5] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [7] 0 0
Fiona Stanley Hospital - Perth
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2000 - Sydney
Recruitment postcode(s) [4] 0 0
4006 - Herston
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment postcode(s) [6] 0 0
6150 - Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06819592
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anthony Delaney, A/Prof
Address 0 0
The George Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dorrilyn Rajbhandari
Address 0 0
Country 0 0
Phone 0 0
+0061 (0)2 8052 4301
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06819592