PEGASUS: Paediatric European Group A Streptococcal United Study.

• Sponsor: Noordwest Ziekenhuisgroep (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06058117
• Collaborator: European Society for Paediatric Infectious Diseases (Other), Medical University of Graz (Other), University Hospital Munich (Other), National and Kapodistrian University of Athens (Other), Mitera Hospital (Other), Children's hospital Iceland (Other), University of Padova (Other), Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other), Riga Stradins University (Other), Maasstad Hospital (Other), HagaZiekenhuis (Other), Leiden University Medical Center (Other), Wroclaw Medical University (Other), University Medical Centre Ljubljana (Other), Hospital Clínico Universitario de Santiago de Compostela (Other), Hospital Universitario 12 de Octubre (Other), Hospital Universitario La Paz (Other), Gregorio Marañón Hospital (Other), Karolinska Institutet (Other), Imperial College London (Other), University of Liverpool (Other), Newcastle University (Other)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 26.4
• Patients Per Site Per Month: 19

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Invasive Group A Beta-Haemolytic Streptococcal Disease	Other: No intervention

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: PEGASUS: Paediatric European Group A Streptococcal United Study.
• Actual Study Start Date: Sep 20, 2023
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
children with invasive group A streptococcal disease children with invasive group A streptococcal disease or other invasive or emergent infectious disease	Other: No intervention; no intervention, this is an observational study

Outcome Measures

Primary Outcome Measures

1. What is the incidence of iGAS in children before, during and after COVID NPIs in different European countries? [2018-2025]

2. Is there a change in clinical phenotypes and outcome during these periods? [2018-2025]

Secondary Outcome Measures

1. Is there a change in emm types and other virulence factors during these periods [2018-2025]

2. Are there differences in antimicrobial resistance between periods and between 4. Are there differences in antimicrobial resistance between periods and between countries [2018-2025]

3. Can we identify risk factors for iGAS infection (e.g., preceding infections, age)? [2018-2025]

4. Can we explain differences between countries (e.g., differences in vaccination strategies, NPIs or emm types) [2018-2025]

5. Can we use this research network for early alarming on other invasive and emergent infectious diseases in children [2018-2025]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Noordwest Ziekenhuisgroep	Alkmaar	NH	Netherlands	1815 JD

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dorine Borensztajn, Principal investigator, MD, PhD, MSc., Noordwest Ziekenhuisgroep
• ClinicalTrials.gov Identifier: NCT06058117
• Other Study ID Numbers: 1.2
• First Posted: Sep 28, 2023
• Last Update Posted: Sep 28, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 28, 2023