Paediatric European Group A Streptococcal United Study.

NCT06058117 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2023-09-28

No results posted yet for this study

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.

Conditions

  • Invasive Group A Beta-Haemolytic Streptococcal Disease

Interventions

OTHER

No intervention

no intervention, this is an observational study

Sponsors & Collaborators

  • European Society for Paediatric Infectious Diseases

    collaborator OTHER
  • Medical University of Graz

    collaborator OTHER
  • University Hospital Munich

    collaborator OTHER
  • National and Kapodistrian University of Athens

    collaborator OTHER
  • Mitera Hospital

    collaborator OTHER
  • Children's hospital Iceland

    collaborator UNKNOWN
  • University of Padova

    collaborator OTHER
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    collaborator OTHER
  • Riga Stradins University

    collaborator OTHER
  • Maasstad Hospital

    collaborator OTHER
  • HagaZiekenhuis

    collaborator OTHER
  • Leiden University Medical Center

    collaborator OTHER
  • Wroclaw Medical University

    collaborator OTHER
  • University Medical Centre Ljubljana

    collaborator OTHER
  • Hospital Clínico Universitario de Santiago de Compostela

    collaborator UNKNOWN
  • Hospital Universitario 12 de Octubre

    collaborator OTHER
  • Hospital Universitario La Paz

    collaborator OTHER
  • Gregorio Marañón Hospital

    collaborator OTHER
  • Karolinska Institutet

    collaborator OTHER
  • Imperial College London

    collaborator OTHER
  • University of Liverpool

    collaborator OTHER
  • Newcastle University

    collaborator OTHER
  • Noordwest Ziekenhuisgroep

    lead OTHER

Eligibility

Min Age
0 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-20
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06058117 on ClinicalTrials.gov