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临床试验/NCT03815357
NCT03815357已完成不适用

What is the Incidence of an Immune Disorder in Children With Invasive Pneumococcal Disease (IPD)? A Prospective Cohort Study.

Murdoch Childrens Research Institute6 个研究点 分布在 2 个国家目标入组 380 人开始时间: 2017年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
380
试验地点
6
主要终点
types of immunodeficiency associated with children who present with invasive pneumococcal disease

研究概览

简要总结

This is a multicentre prospective audit to determine the incidence of immunodeficiency in children with IPD.

Aims and/or research question of the project

  1. To determine the incidence of primary immunodeficiency in children >2 years who present with IPD
  2. To determine the types of immunodeficiency associated with IPD in children

研究设计

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

入排标准

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

入选标准

  • Children aged 0 to 18 years admitted to one of the six centres with IPD.

排除标准

  • Children who do not fulfil the age criteria for immunological evaluation at that particular site e.g. aged <2 years at Royal Children's Hospital.
  • Children with a known underlying condition predisposing to IPD i.e. nephrotic syndrome.

结局指标

主要结局

types of immunodeficiency associated with children who present with invasive pneumococcal disease

时间窗: 3 years

This will be determined based on the testing performed by the immunologists.

incidence of primary immunodeficiency in children who present with invasive pneumococcal disease

时间窗: 3 years

This will be picked up upon prospective immunological testing, after identification of patients with invasive pneumococcal disease. A series of tests will be performed depending on the clinical opinion of the immunology team. Such tests may include lymphocyte subsets, complement function, serum immunoglobulin levels, memory B cells, vaccine antibody responses, etc.

次要结局

  • whether increased referrals of children who present with invasive pneumococcal disease for investigation of primary immunodeficiency facilitates early detection(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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