Paediatric European Group A Streptococcal United Study.

Study Overview
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Brief Summary
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Introduction Since 2022 there are reports of a rapid increase in invasive group A streptococcal infections (iGAS) in children in some but not all European countries. Detailed information on this increase is lacking. Furthermore, an increase in other invasive infections as well as the emergence of novel pathogens and disease entities is seen, such as MIS-C and severe hepatitis of unknown origin. Aims To set up a European research network and describe the incidence, risk factors, clinical phenotypes, microbiology and resistance, treatment, and outcomes of iGAS in children across Europe. The network will subsequently be utilized for early alerting regarding the rise of other invasive and emerging infections in children. It will enable swift data collection pertaining to patient characteristics, presentation, progression, and treatment. Methods International, retrospective cohort and observational surveillance study of children 0-18y attending the ED or admitted to the hospital with iGAS. Clinical and microbiological data, national vaccination schedules, and COVID non-pharmaceutical interventions (NPIs) will be collected and compared between countries. Subsequently, the network will be employed to raise alarms regarding the surge of other invasive infections or emerging infections in children. Anonymous data about these novel infections will be collected, similar to the data from iGAS (clinical characteristics and microbiological data). The study is a non-profit study. Significance Our study will describe variation in the clinical phenotypes of iGAS, will aid in the understanding of its association with COVID NPIs and allow for comparison between countries. Furthermore, it will aid in early recognition of invasive and emergent infectious diseases in children and the reduction of outbreaks.

Official Title
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PEGASUS: Paediatric European Group A Streptococcal United Study.

Conditions
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Invasive Group A Beta-Haemolytic Streptococcal Disease

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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All children (1 month-18 years) attending the Emergency Department and/or admitted to the participating hospital - with iGAS infection or other invasive or emergent infectious disease.

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| children with invasive group A streptococcal disease<br>children with invasive group A streptococcal disease or other invasive or emergent infectious disease | Other: No intervention<br>* no intervention, this is an observational study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| What is the incidence of iGAS in children before, during and after COVID NPIs in different European countries? |  | 2018-2025 | 
| Is there a change in clinical phenotypes and outcome during these periods? |  | 2018-2025 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is there a change in emm types and other virulence factors during these periods |  | 2018-2025 | 
| Are there differences in antimicrobial resistance between periods and between 4. Are there differences in antimicrobial resistance between periods and between countries |  | 2018-2025 | 
| Can we identify risk factors for iGAS infection (e.g., preceding infections, age)? |  | 2018-2025 | 
| Can we explain differences between countries (e.g., differences in vaccination strategies, NPIs or emm types) |  | 2018-2025 | 
| Can we use this research network for early alarming on other invasive and emergent infectious diseases in children |  | 2018-2025 |