Paediatric Adaptive Sepsis Platform Trial (PASSPORT)

Project status: Active

Research area: Clinical Sciences > Emergency

We aim to reduce the global burden of sepsis in children.

This study evaluates multiple treatments for sepsis under a single platform using adaptive methods.

This means that treatments can be adjusted over time based on the data collected and ensures all study participants receive the best and most evidence-based care.

This study evaluates multiple treatments for sepsis under a single platform using adaptive methods.

This means that treatments can be adjusted over time based on the data collected and ensures all study participants receive the best and most...

This study evaluates multiple treatments for sepsis under a single platform using adaptive methods.

This means that treatments can be adjusted over time based on the data collected and ensures all study participants receive the best and most evidence-based care.

Overview

Every year, there are around 25.2 million children diagnosed with paediatric sepsis, resulting in 3.4 million deaths worldwide.

The World Health Organization (WHO) has identified paediatric sepsis as a global health priority due to the infection’s severity and the cost to hospitals. Reducing childhood deaths from sepsis is essential if Millennium Development Goals are to be achieved.

Despite significant efforts to improve outcomes for paediatric sepsis, randomised controlled trials (RCTs) have been unable to answer fundamental questions in children with sepsis in an effective and timely way.

As a result, there has been little practice change in the management of childhood sepsis in the last 20 years, and current guidelines are based on low-quality evidence.

About PASSPORT

The Paediatric Adaptive Sepsis Platform Trial (PASSPORT) is a different type of study called an adaptive platform trial (APT). APTs are a new, cost-effective trial design that helps researchers assess multiple treatments, and interactions between treatments, at the same time.

PASSPORT will be conducted in multiple centres across Australia and New Zealand and scaled to include other high-income countries as well as low and middle-income countries.

This adaptive platform trial will evaluate multiple interventions for paediatric sepsis, allowing us to quickly adjust treatments based in response to collected data. We believe this approach will help us find effective treatments quicker and improve global outcomes for critically ill children with sepsis.

The trial will include children aged one month to 18 years with suspected or confirmed sepsis and who meet the study criteria.

Purpose

The purpose of PASSPORT is to reduce the global burden of sepsis in children.

Aim

PASSPORT will generate evidence for multiple treatments to improve sepsis outcomes in children globally.

Objectives

To develop clinical trial capacity and infrastructure to support global sepsis research in children within an adaptive trial framework.
To collaborate with healthcare stakeholders to answer priority research questions.
To partner with consumers, priority groups, and policymakers to ensure research questions are important and feasible for implementation.
To generate high-quality evidence for the efficacy and safety of multiple sepsis treatments to inform clinical practice.
To translate research findings into tangible improvements in health outcomes and healthcare delivery.

Research team

Researcher	Organisation
Associate Professor Elliot Long	Emergency, Clinical Sciences, Murdoch Children’s Research Institute
Professor Franz E Babl	Emergency, Clinical Sciences, Murdoch Children’s Research Institute
Professor Katherine Lee	Clinical Epidemiology & Biostatistics (CEBU), Population Health, Murdoch Children’s Research Institute
Professor Andrew Davidson	Melbourne Children's Trial Centre, Murdoch Children’s Research Institute
Professor Stuart Dalziel	Department of Surgery and Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand Children’s Emergency Department, Starship Children’s Hospital, Auckland, New Zealand
Associate Professor Shane George	Department of Emergency Medicine and Children’s Critical Care, Gold Coast University Hospital, Queensland, Australia School of Medicine and Menzies Health Institute Queensland, Griffith University, Queensland, Australia Child Health Research Centre, The University of Queensland, Queensland, Australia
Professor Kim Dalziel	Health Services, The Centre for Community Child Health, Murdoch Children’s Research Institute
Ms Kate Rawnsley	Victorian Infant Brain Studies (VIBeS), Clinical Sciences, Murdoch Children’s Research Institute
Professor Simon Craig	Department of Emergency Medicine, Monash Medical Centre, Victoria, Australia Department of Paediatrics, School of Clinical Sciences, Monash University, Victoria, Australia Emergency, Clinical Sciences, Murdoch Children’s Research Institute
Professor Meredith Borland	Department of Emergency Medicine, Perth Children’s Hospital, Western Australia, Australia Division of Emergency Medicine and Paediatrics, School of Medicine, University of Western Australia, Western Australia, Australia
Ms Cate Wilson	Emergency, Clinical Sciences, Murdoch Children’s Research Institute
Ms Amanda Williams	Emergency, Clinical Sciences, Murdoch Children’s Research Institute
Dr Sarah McNab	Department of General Medicine, The Royal Children’s Hospital, Victoria, Australia Clinical Sciences, Murdoch Children’s Research Institute
Dr Adriana Yock-Corrales	Department of Emergency Medicine, Hospital Nacional de Niños, San Jose, Costa Rica