Australia is a vast country, with children’s hospitals centralised in the big cities. Let me tell you a story of a young patient named Lara whom we cared for at the Perth Children’s Hospital. She comes from a very remote community in the Kimberley, > 3000km from Perth. She started with a fever and a sore ankle and was flown from her community to hospital in the Kimberley. She was started on antibiotics at hospital in the Kimberley – already 1000 km from home - but was getting sicker and sicker and needed surgery and ICU, so was flown from the Kimberley to Perth. She was in Perth for 5 weeks for 2 operations and another week in the ICU before finally getting back to her community and country in the Kimberley (see video). The SNAP trial aims to improve the health care experience for children like this one.
Current situation of Staph aureus bloodstream infection in childhood
Staph aureus bloodstream infection has become a major cause of community acquired bloodstream infection in Australian children in the 21st century, affecting approximately 450 Australian children and young people each year:
• On average, each child or young person is hospitalised for 2 weeks
• 20% are admitted to the Intensive Care Unit (ICU)
• The economic costs for hospitalisation for Staph aureus bloodstream infection in Australia are > $AUD 10 million per year
• Of those hospitalised, up to 20 children (5%) will not survive.
There is currently little evidence to guide antibiotic treatment of Staph aureus bloodstream infection.
Evidence to inform guidelines and clinical practice for children presenting with Staph aureus bloodstream infection is urgently needed. SNAP-PY will include neonates, children and adolescents into the already established Staph aureus Network Adaptive Platform (SNAP) trial, the largest global study to inform the evidence for treatment of Staph aureus bloodstream infection.
The overall aim of SNAP and SNAP-PY is to establish the best antibiotic treatment, to save lives, improve quality of life and reduce the length of hospital stays for all people who present with Staph aureus bloodstream infection.
A SNAP-PY Introduction
In Australia alone, more children are treated for Staph aureus bloodstream infection every year than have ever been included in treatment trials for this condition.
The SNAP trial will aim to enrol up to 1000 children, making it the world’s first platform trial to randomise children and adults in the same trial and inform best practice treatment of Staph aureus bloodstream infection across the life-course.
We believe that mortality in children with Staph aureus bloodstream infection can be reduced by finding the best available antibiotic treatment. Children in hospitals that are participating in the trial with Staph aureus bloodstream infection will be eligible for inclusion in the SNAP-PY trial to investigate the optimal antibiotic strategy for Staph aureus bloodstream infection treatment.
Paediatric hospitals in Australia, New Zealand and Canada will start to recruit children in 2022, with potential for children to join in other countries running the SNAP trial in years to come.
We will use the same primary endpoint as SNAP, which is looking at patient status at day 90 since infection was detected. However, mortality is uncommon in children (3-5%) compared to adults (15-20%). Therefore, the statistical model stratifies by adult and paediatric populations, using hierarchical borrowing across the two groups. Pre-specified stopping rules will be applied to the adult population (with borrowing from children), and when a conclusion is declared in adults, the treatment effect size will also be reported for children. Using the same protocol and statistical model for adults and children will produce much stronger evidence than extrapolating to children from adult data alone.
SNAP is a world first trial in infectious diseases, incorporating children alongside adults, and will be the largest clinical trial of Staph aureus bloodstream infection in children, providing the strongest evidence for treatment of children with Staph aureus bloodstream infection worldwide.
To learn and hear more about SNAP-PY and to listen to Lara’s story, please click here to watch a short video.