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Clinical Trials/NCT06058117
NCT06058117RecruitingNot Applicable

PEGASUS: Paediatric European Group A Streptococcal United Study.

Noordwest Ziekenhuisgroep1 site in 1 country500 target enrollmentStarted: September 20, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
500
Locations
1
Primary Endpoint
What is the incidence of iGAS in children before, during and after COVID NPIs in different European countries?

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Eligibility Criteria

Ages
0 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

What is the incidence of iGAS in children before, during and after COVID NPIs in different European countries?

Time Frame: 2018-2025

Is there a change in clinical phenotypes and outcome during these periods?

Time Frame: 2018-2025

Secondary Outcomes

  • Is there a change in emm types and other virulence factors during these periods(2018-2025)
  • Can we identify risk factors for iGAS infection (e.g., preceding infections, age)?(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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dorine Borensztajn

Principal investigator, MD, PhD, MSc.

Noordwest Ziekenhuisgroep

Study Sites (1)

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