PEGASUS
PEGASUS: Paediatric European Group A Streptococcal United Study.
Sponsor study identifier
observational
500
1 country
1
Study Start
September 20, 2023
Actual (reported)Primary Completion
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 20, 2023
Actual (reported)September 21, 2023
Actual (reported)September 28, 2023
Actual (reported)December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
children with invasive group A streptococcal disease or other invasive or emergent infectious disease
no intervention, this is an observational study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Definitions Confirmed iGAS infection: * Clinical presentation consistent with iGAS\* AND * Isolation of group A streptococcus by culture or PCR or antigen detection test from a normally sterile body site Probable iGAS infection: * Clinical presentation consistent with STSS or necrotizing fasciitis \* AND * Isolation of group A streptococcus by culture or PCR or antigen detection test from a non-sterile body site AND * No evidence of other pathogen explaining the clinical presentation * Clinical presentation consistent with iGAS: Clinically severe illness, such as sepsis, septic shock, STSS, pneumonia, meningitis, arthritis, osteomyelitis, myositis or necrotizing fasciitis
Noordwest Ziekenhuisgroep
Alkmaar, North Holland, 1815 JD, Netherlands
First Submitted
September 21, 2023
First Posted
September 28, 2023
Study Start
September 20, 2023
Actual (reported)Primary Completion
December 1, 2025
Estimated (date passed)Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 28, 2023
Record last verified: 2023-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: