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Pragmatic Adaptive Trial for Respiratory Infection in Children (PATRIC) Clinical Registry protocol
Rebecca Pavlos1, Mejbah U Bhuiyan1, Mark Jones2
1Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Nedlands, Western Australia, Australia.
Insights
The Pragmatic Adaptive Trial for Respiratory Infections in Children (PATRIC) Clinical Registry collects data on pediatric acute respiratory infections (ARI) to improve treatment. This registry will inform trials to optimize care for children with ARI.
Area of Science:
- Pediatric infectious diseases
- Clinical trial registries
- Respiratory medicine
Background:
- Acute respiratory infections (ARI) are a leading cause of hospitalization in children.
- There are significant knowledge gaps in the effective management of pediatric ARI.
- Optimizing ARI care requires robust data on current treatments and outcomes.
Purpose of the Study:
- To establish the Pragmatic Adaptive Trial for Respiratory Infections in Children (PATRIC) Clinical Registry.
- To evaluate current treatments and outcomes for ARI in diverse pediatric populations.
- To provide a data platform for future PATRIC clinical trials aimed at optimizing pediatric ARI care.
Main Methods:
- A single-center, prospective observational registry.
- Recruitment from a tertiary pediatric Emergency Department in Western Australia.
- Collection of demographic, clinical, treatment, and outcome data.
Main Results:
- The registry characterizes antibiotic utilization in children with ARI.
- It improves understanding of ARI outcomes in pediatric patients.
- Data collected will inform clinical trials to enhance ARI management.
Conclusions:
- The PATRIC Clinical Registry is essential for advancing pediatric ARI research.
- It will facilitate evidence-based improvements in ARI treatment and management.
- This initiative aims to optimize healthcare outcomes for children suffering from respiratory infections.
Introduction:
Acute respiratory infections (ARI) are the most common cause of paediatric hospitalisation. There is an urgent need to address ongoing critical knowledge gaps in ARI management. The Pragmatic Adaptive Trial for Respiratory Infections in Children (PATRIC) Clinical Registry will evaluate current treatments and outcomes for ARI in a variety of paediatric patient groups. The registry will provide a platform and data to inform a number of PATRIC clinical trials, testing various interventions in ARI treatment and management to optimise paediatric ARI care.
Methods And Analysis:
The PATRIC Clinical Registry is a single-centre, prospective observational registry recruiting from a tertiary paediatric Emergency Department in Western Australia. Through characterising demographic, clinical, treatment and outcome data, the PATRIC Clinical Registry will improve our understanding of antibiotic utilisation and ARI outcomes in children.
Ethics And Dissemination:
The PATRIC Clinical Registry is conducted in accordance with the Declaration of Helsinki, and the International Council for Harmonisation (ICH) Guidelines for Good Clinical Practice (CPMP/ICH/13595) July 1996. Approval is provided by the Child and Adolescent Health Service Human Research Ethics Committee (HREC). Study results will be communicated by presentation and publication (HREC: RGS0000003078.) TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12619000903189. UTN: U1111-1231-3365.
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