Impact of Respiratory Viral Infections in Infants With Cystic Fibrosis. (PREVIMUC)
Clinical and Microbiological Impact of Respiratory Viral Infections in the Short and Medium Term in Infants (<24 Months) With Cystic Fibrosis.
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Bron、法国、69677
- Cystic Fibrosis Pediatric Reference Centrer, Hospices Civils de Lyon
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- infant <24 months with cystic fibrosis
Exclusion Criteria:
- patient >24 months
学习计划
研究是如何设计的？
设计细节
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：cystic fibrosis infants
1 year follow-up in CF infants
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1 year follow-up in CF infants with clinical, microbiological and therapeutic assessments
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Number of Respiratory Viral Infection
大体时间：up to 12 months
|
up to 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Identification of respiratory viruses in throat-swabs
大体时间：up to 12 months
|
A panel of 10 viruses will be tested using polymerase chain reaction (PCR) and RT-PCR technology.
|
up to 12 months
|
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Number of antibiotics treatments (oral or IV)
大体时间：up to 12 months
|
up to 12 months
|
|
|
Number of bronchodilator administrations
大体时间：up to 12 months
|
up to 12 months
|
|
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Number of corticosteroids administrations
大体时间：up to 12 months
|
up to 12 months
|
|
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Number of hospitalization or hospital admission due to upper or lower RVI
大体时间：up to 12 months
|
up to 12 months
|
|
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Identification of bacterial flora in throat-swabs
大体时间：up to 12 months
|
up to 12 months
|
合作者和调查者
调查人员
- 首席研究员：Stéphanie VRIELYNCK, MD、Cystic Fibrosis Pediatric Reference Centrer, Hospices Civils de Lyon, 69677 Bron Cedex, France
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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