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临床试验/NCT06058117
NCT06058117招募中不适用

PEGASUS: Paediatric European Group A Streptococcal United Study.

Noordwest Ziekenhuisgroep1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
What is the incidence of iGAS in children before, during and after COVID NPIs in different European countries?

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
0 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

What is the incidence of iGAS in children before, during and after COVID NPIs in different European countries?

时间窗: 2018-2025

Is there a change in clinical phenotypes and outcome during these periods?

时间窗: 2018-2025

次要结局

  • Is there a change in emm types and other virulence factors during these periods(2018-2025)
  • Can we identify risk factors for iGAS infection (e.g., preceding infections, age)?(2018-2025)
  • Can we use this research network for early alarming on other invasive and emergent infectious diseases in children(2018-2025)
  • Are there differences in antimicrobial resistance between periods and between 4. Are there differences in antimicrobial resistance between periods and between countries(2018-2025)
  • Can we explain differences between countries (e.g., differences in vaccination strategies, NPIs or emm types)(2018-2025)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dorine Borensztajn

Principal investigator, MD, PhD, MSc.

Noordwest Ziekenhuisgroep

研究点 (1)

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