Paediatric European Group A Streptococcal United Study.
- Conditions
- Invasive Group A Beta-Haemolytic Streptococcal Disease
- Interventions
- Other: No intervention
- Registration Number
- NCT06058117
- Lead Sponsor
- Noordwest Ziekenhuisgroep
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description children with invasive group A streptococcal disease No intervention children with invasive group A streptococcal disease or other invasive or emergent infectious disease
- Primary Outcome Measures
Name Time Method 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
Name Time Method Can we identify risk factors for iGAS infection (e.g., preceding infections, age)? 2018-2025 Is there a change in emm types and other virulence factors during these periods 2018-2025 Can we use this research network for early alarming on other invasive and emergent infectious diseases in children 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 explain differences between countries (e.g., differences in vaccination strategies, NPIs or emm types) 2018-2025
Trial Locations
- Locations (1)
Noordwest Ziekenhuisgroep
🇳🇱Alkmaar, NH, Netherlands