PEGASUS: Paediatric European Group A Streptococcal United Study.

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Noordwest Ziekenhuisgroep
RECRUITING
Alkmaar
Contact Information
Primary
Dorine Borensztajn, MD, PhD, MSc
dm.borensztajn@nwz.nl
+31880855262
Time Frame
Start Date: 2023-09-20
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 500
Treatments
children with invasive group A streptococcal disease
children with invasive group A streptococcal disease or other invasive or emergent infectious disease
Related Therapeutic Areas
Sponsors
Collaborators: Mitera Hospital, HagaZiekenhuis, University Medical Centre Ljubljana, Karolinska Institutet, Hospital Universitario 12 de Octubre, Newcastle University, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University of Liverpool, National and Kapodistrian University of Athens, Hospital Universitario La Paz, Leiden University Medical Center, Children's hospital Iceland, Wroclaw Medical University, University of Padova, European Society for Paediatric Infectious Diseases, Riga Stradins University, Maasstad Hospital, University Hospital Munich, Imperial College London, Medical University of Graz, Gregorio Marañón Hospital, Hospital Clínico Universitario de Santiago de Compostela
Leads: Noordwest Ziekenhuisgroep

This content was sourced from clinicaltrials.gov