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PATRIC: Pragmatic Adaptive Trial for Respiratory Infections in Children

Investigators: Chris Blyth, Julie Marsh, Mejbah Bhuiyan, Peter Richmond, Rebecca Pavlos, Tom Snelling

External collaborators: Meredith Borland (Emergency Department, Perth Children's Hospital), Andrew Martin (Department of General Paediatrics, Perth Children's Hospital) Sharon O'Brien

The Pragmatic Adaptive Trial for Respiratory Infections in Children (PATRIC) will be the first pragmatic adaptive paediatric ARI platform trial, nested within a clinical patient registry, utilising information drawn from existing hospital resources. The PATRIC clinical registry (already funded) commenced recruiting in February 2020, collecting demographic data, risk factors, treatment and parent-reported outcomes measures in children presenting to Perth Children’s Hospital ED with fever and cough. Personalised educational discharge resources to assist parents post discharge will be provided and outcome data compared in children prescribed different treatments.

The next step towards an evidence-based approach to pneumonia care, is to establish the PATRIC pilot study, the critical first step towards the PATRIC platform trial. The pilot study seeks to:

  1. Establish, test and implement a data entry and randomisation web-interface, suitable for use in a national multi-centred pragmatic adaptive pneumonia trial.
  2. Demonstrate the willingness of physicians and parents to enrol their patients and children in a pragmatic adaptive trial of pneumonia management.
  3. Define the optimal length of amoxicillin therapy in children with pneumonia.
  4. Establish the processes to address the proposed suite of interventions to be included in a large multi-centred platform trial and apply for competitive funding to commence such a trial.

PATRIC seeks to bring about a paradigm shift in paediatric care, a move away from the evidence-informed approach, in which evidence gathering is a step removed from implementation, to a new evidence-embedded paradigm in which evidence gathering and implementation are inextricably connected. Through PATRIC, we will establish the trial from which current and future key questions posed by clinicians managing paediatric pneumonia can be answered concurrently, rather than sequentially and directly translated into changes in clinical care. Moreover, PATRIC will be a national demonstration project proving that adaptive trials can be used to improve the management of common paediatric conditions and embed research findings into practice.

Funding: PATRIC is funded by the Ramaciotti Foundation, The University of Western Australia and The Kids Research Institute Australia.