Mpox Paediatric and Adolescent Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,108
- 试验地点
- 11
- 主要终点
- Proportion of participants with severe mpox.
研究概览
简要总结
The goal of this multicentre, observational study on mpox in infants, children and adolescents is to increase knowledge about mpox infection and its associated disease in infants, children and adolescents. This will be done through the development of a harmonized system that will allow standard collection of information on demographics, clinical symptoms, clinical course, treatments and outcomes. The study will be carried out in three potential phases: Phase 1 entails the rapid development of an online paediatric registry collecting anonymised data from routine care on infants, children and adolescents with laboratory-confirmed mpox virus infection. If warranted, the study will proceed to Phase 2, an enhanced observational study of children and adolescents with confirmed mpox virus infection, if more detailed prospective data collection would aid the public health response. There is also the potential to initiate Phase 3, comprising of nested sub-studies to investigate specific research questions in this population.
详细描述
The primary objective of this multicentre observational study is to use a harmonised data system for the standard data collection and analysis to describe the presentation, clinical course and outcomes of laboratory-confirmed mpox virus infection in infants, children and adolescents by:
- monitoring the temporal and geographical distribution of mpox infection in the paediatric and adolescent population, including in specific paediatric/adolescent groups, such as those with underlying conditions or with congenital mpox;
- describing the epidemiology and clinical presentation of the disease, including outcomes of treatment administered as part of routine care;
- describing high risk populations , including identifying factors associated with severe disease and death.
Phase 1 consists of the rapid development of an online registry for standard collection of data on infants, children and adolescents with laboratory-confirmed mpox infection, including adolescent girls who acquired mpox in pregnancy, and infants who acquired mpox through vertical transmission. All data will be fully anonymised, allowing rapid implementation in many countries without the need for ethics approval, where applicable.
If additional data collection would aid the public health response, the investigators might additionally include a second phase (Phase 2) of the project, with the aim to implement an enhanced prospective observational study of children and adolescents with confirmed mpox infection. This part of the project, if activated, will be a consented study collecting detailed data over the course of the disease.
Phase 3: initiation of nested sub-studies within the consented observational study (Phase 2) to investigate specific research questions in this population, including collection of samples, where necessary, for analysis and/or storage in a biobank. Each sub-study will require its own protocol and informed consent.
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
- 否
入选标准
- •all infants, children and adolescents aged <18 years at the time of mpox diagnosis, with laboratory-confirmed mpox infection, as per national guidelines;
- •mothers of eligible infants who are diagnosed with mpox at 28days or less are included in the study to collect maternal data on pregnancy and delivery
排除标准
- •adolescents aged over 18 years old at mpox diagnosis.
结局指标
主要结局
Proportion of participants with severe mpox.
时间窗: Throughout study completion, expected 2 years from study start.
Severe mpox infection as measured by, for example, mortality, ICU admission, receipt of interventions
Proportion of Participants With Severe Mpox.
时间窗: Throughout the study period. Participants are enrolled over a period of 2 years 7 months, participants' outcomes are recorded at 28 days.
Severe mpox infection as measured by, for example, mortality, ICU admission, receipt of interventions
次要结局
- Number of infants born to women infected with mpox in pregnancy, who are vertically infected with mpox.(Throughout study completion, expected 2 years from study start.)
- Number of Infants Born to Women Infected With Mpox in Pregnancy, Who Are Vertically Infected With Mpox.(Throughout the study period. Participants are enrolled over a period of 2 years 7 months, participants' outcomes are recorded at 28 days.)