Clinical and Microbiological Impact of Respiratory Viral Infections in the Short and Medium Term in Infants (<24 Months) With Cystic Fibrosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Number of Respiratory Viral Infection
研究概览
简要总结
Respiratory Viral Infections (RVI) are particularly frequent in young children. Old data mention the deleterious role of some viruses such as the Respiratory Syncytial Virus in young children with cystic fibrosis (CF). However, recent epidemiological data on RVI in CF children are rare and the impact of most frequent viruses such as human rhinoviruses is usually not correctly evaluated.
The aim of this study is to assess the frequency of lower and upper RVI during a 1 year follow-up in CF infants and to evaluate the impact of RVI at a clinical, microbiological and therapeutic level.
Our hypothesis is that frequent and/or clinically severe RVIs have the worst impact in the short term and without any particular link with a specific virus as previously described.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- — 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infant <24 months with cystic fibrosis
排除标准
- •patient >24 months
结局指标
主要结局
Number of Respiratory Viral Infection
时间窗: up to 12 months
次要结局
- Number of hospitalization or hospital admission due to upper or lower RVI(up to 12 months)
- Identification of respiratory viruses in throat-swabs(up to 12 months)
- Number of corticosteroids administrations(up to 12 months)
- Number of antibiotics treatments (oral or IV)(up to 12 months)
- Number of bronchodilator administrations(up to 12 months)
- Identification of bacterial flora in throat-swabs(up to 12 months)