Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06058117
Status:
RECRUITING
Last Update Posted:
2023-09-28
First Post:
2023-09-21
Brief Title:
Paediatric European Group A Streptococcal United Study
Sponsor:
Noordwest Ziekenhuisgroep
Organization:
Noordwest Ziekenhuisgroep
Study Overview
Official Title:
PEGASUS Paediatric European Group A Streptococcal United Study
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEGASUS
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None