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Paediatric European Group A Streptococcal United Study.

PEGASUS: Paediatric European Group A Streptococcal United Study.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06058117
Acronym
PEGASUS
Enrollment
500
Registered
2023-09-28
Start date
2023-09-20
Completion date
2025-12-01
Last updated
2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive Group A Beta-Haemolytic Streptococcal Disease

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.

Interventions

OTHERNo intervention

no intervention, this is an observational study

Sponsors

European Society for Paediatric Infectious Diseases
CollaboratorOTHER
Medical University of Graz
CollaboratorOTHER
University Hospital Munich
CollaboratorOTHER
National and Kapodistrian University of Athens
CollaboratorOTHER
Mitera Hospital
CollaboratorOTHER
Children's hospital Iceland
CollaboratorUNKNOWN
University of Padova
CollaboratorOTHER
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
CollaboratorOTHER
Riga Stradins University
CollaboratorOTHER
Maasstad Hospital
CollaboratorOTHER
HagaZiekenhuis
CollaboratorOTHER
Leiden University Medical Center
CollaboratorOTHER
Wroclaw Medical University
CollaboratorOTHER
University Medical Centre Ljubljana
CollaboratorOTHER
Hospital Clínico Universitario de Santiago de Compostela
CollaboratorUNKNOWN
Hospital Universitario 12 de Octubre
CollaboratorOTHER
Hospital Universitario La Paz
CollaboratorOTHER
Gregorio Marañón Hospital
CollaboratorOTHER
Karolinska Institutet
CollaboratorOTHER
Imperial College London
CollaboratorOTHER
University of Liverpool
CollaboratorOTHER
Newcastle University
CollaboratorOTHER
Noordwest Ziekenhuisgroep
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
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 periods2018-2025
Can we use this research network for early alarming on other invasive and emergent infectious diseases in children2018-2025
Can we explain differences between countries (e.g., differences in vaccination strategies, NPIs or emm types)2018-2025
Are there differences in antimicrobial resistance between periods and between 4. Are there differences in antimicrobial resistance between periods and between countries2018-2025

Countries

Netherlands

Contacts

Primary ContactDorine Borensztajn, MD, PhD, MSc
dm.borensztajn@nwz.nl+31880855262

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026