Clinical trial NCT06058117: Paediatric European Group A Streptococcal United Study.
Official title: PEGASUS: Paediatric European Group A Streptococcal United Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Invasive Group A Beta-Haemolytic Streptococcal Disease
Lead sponsor: Noordwest Ziekenhuisgroep
Sponsor class: OTHER
Collaborators: name: European Society for Paediatric Infectious Diseases
name: Medical University of Graz
name: University Hospital Munich
name: National and Kapodistrian University of Athens
name: Mitera Hospital
name: Children's hospital Iceland
name: University of Padova
name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Riga Stradins University
name: Maasstad Hospital
name: HagaZiekenhuis
name: Leiden University Medical Center
name: Wroclaw Medical University
name: University Medical Centre Ljubljana
name: Hospital Clínico Universitario de Santiago de Compostela
name: Hospital Universitario 12 de Octubre
name: Hospital Universitario La Paz
name: Gregorio Marañón Hospital
name: Karolinska Institutet
name: Imperial College London
name: University of Liverpool
name: Newcastle University
First posted: 2023-09-28
Enrollment: 500
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.


Eligibility 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.

Primary outcomes:
measure: What is the incidence of iGAS in children before, during and after COVID NPIs in different European countries?
timeFrame: 2018-2025
measure: Is there a change in clinical phenotypes and outcome during these periods?
timeFrame: 2018-2025
Secondary outcomes:
measure: Is there a change in emm types and other virulence factors during these periods
timeFrame: 2018-2025
measure: Are there differences in antimicrobial resistance between periods and between 4. Are there differences in antimicrobial resistance between periods and between countries
timeFrame: 2018-2025
measure: Can we identify risk factors for iGAS infection (e.g., preceding infections, age)?
timeFrame: 2018-2025
measure: Can we explain differences between countries (e.g., differences in vaccination strategies, NPIs or emm types)
timeFrame: 2018-2025
measure: Can we use this research network for early alarming on other invasive and emergent infectious diseases in children
timeFrame: 2018-2025
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
state: NH
Study officials:
References: