NCT03613636已完成不适用
The Role of Adaptive Immune Responses to Mycoplasma Pneumoniae in Pathogenesis and Diagnosis of Community-acquired Pneumonia (CAP) in Children: an Observational Single-center Study (myCAP Study)
University Children's Hospital, Zurich0 个研究点目标入组 490 人开始时间: 2016年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 490
- 主要终点
- Change in numbers of M. pneumoniae-specific ASCs and M. pneumoniae-specific INF-γ-secreting T cells in blood from inclusion (day 0) to 1-month follow-up (day 28)
研究概览
简要总结
To investigate the Mycoplasma pneumoniae-specific circulating antibody-secreting cell (ASC) response and Mycoplasma pneumoniae-specific interferon (INF)-γ-secreting T cell response, along with polymerase chain reaction (PCR) and serology, in a cohort of children with community-acquired pneumonia (CAP) and controls.
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
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CAP cohort:
- •Children of age 3 to 18 years;
- •In- and outpatients;
- •Clinically diagnosed community-acquired pneumonia (CAP);
- •Healthy control cohort:
- •Healthy asymptomatic children of age 3 to 18 years undergoing an elective surgical procedure;
- •Family control cohort:
- •Family members of index CAP patients.
排除标准
- •Hospital-acquired pneumonia;
- •Immunodeficiencies;
- •Chronic lung disorders.
结局指标
主要结局
Change in numbers of M. pneumoniae-specific ASCs and M. pneumoniae-specific INF-γ-secreting T cells in blood from inclusion (day 0) to 1-month follow-up (day 28)
时间窗: At day 0 (inclusion, disease presentation) and at day 28 (follow-up, disease resolution)
Enzyme-linked immunospot (ELISpot) assay and flow cytometry
次要结局
- Change in total and M. pneumoniae-specific antibody levels (immunoglobulin (Ig)G, IgM, IgA) from inclusion (day 0) to 1-month follow-up (day 28)(At day 0 (inclusion, disease presentation) and at day 28 (follow-up, disease resolution))
- Outcome of community-acquired pneumonia (CAP) assessed by clinical assessment of body temperature (°C) and respiratory rate (per minute) at 1-month follow-up (day 28)(At day 28 (follow-up))
- Change in M. pneumoniae DNA levels in respiratory samples from inclusion (day 0) to 1-month follow-up (day 28)(At day 0 (inclusion, disease presentation) and at day 28 (follow-up, disease resolution))
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