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.