Paediatric European Group A Streptococcal United Study.

Invasive Group A Beta-Haemolytic Streptococcal Disease Clinical Trial

— PEGASUS  

Official title:

PEGASUS: Paediatric European Group A Streptococcal United Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06058117
• Other study ID #: 1.2
• Status: Recruiting
• Start date: September 20, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: September 2023
• Source: Noordwest Ziekenhuisgroep
• Contact: Dorine Borensztajn, MD, PhD, MSc
• Phone: +31880855262
• Email: dm.borensztajn[@]nwz.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Invasive Group A Beta-Haemolytic Streptococcal Disease

Intervention

Other:
• No intervention
no intervention, this is an observational study

Locations

Country	Name	City	State
Netherlands	Noordwest Ziekenhuisgroep	Alkmaar	NH

Sponsors (23)

Lead Sponsor

Collaborator

Noordwest Ziekenhuisgroep

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

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	What is the incidence of iGAS in children before, during and after COVID NPIs in different European countries?		2018-2025
Primary	Is there a change in clinical phenotypes and outcome during these periods?		2018-2025
Secondary	Is there a change in emm types and other virulence factors during these periods		2018-2025
Secondary	Are there differences in antimicrobial resistance between periods and between 4. Are there differences in antimicrobial resistance between periods and between countries		2018-2025
Secondary	Can we identify risk factors for iGAS infection (e.g., preceding infections, age)?		2018-2025
Secondary	Can we explain differences between countries (e.g., differences in vaccination strategies, NPIs or emm types)		2018-2025
Secondary	Can we use this research network for early alarming on other invasive and emergent infectious diseases in children		2018-2025