Pilot Feasibility Study for Cystic Fibrosis Sputum Validation for the Molecular Diagnosis of Respiratory Viral Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Concordance of viral type detected in both samples for each participant: sputum and nasopharyngeal swab
研究概览
简要总结
The aim of this pilot study is to demonstrate the feasibility of viral biomolecular diagnosis in sputum compared to nasopharyngeal swab in cystic fibrosis acute respiratory infection.
详细描述
In cystic fibrosis (CF), patients face polymicrobial airway infections. Besides bacteria, viruses are now also considered as important agents in lung function deterioration. No strategy has been established on the optimal sampling for respiratory viral molecular diagnostic in CF. Nasopharyngeal swabs (NP) are recommended for respiratory viral screening in non-CF patients but are invasive and sometimes painful for patients. As sputa are non invasive and collected for bacterial monitoring in CF patients they could represent a convenient alternative to NP swabs.
This study's aim is to define whether viral screening give concordant results between sputa and NP swabs.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant with Cystic Fibrosis
- •Participant able to expectorate
- •Participant with sign of acute respiratory infection
排除标准
- •participant not able to expectorate
- •patient refusing to participate
结局指标
主要结局
Concordance of viral type detected in both samples for each participant: sputum and nasopharyngeal swab
时间窗: Day 1
Comparison of per participant results of viral molecular detection in sputum and nasopharyngeal swab. Concordance=same virus(es) or no virus detected in both sample. no concordance=different viruses detected in each sample or virus(es) detected in only one sample and not in the other
次要结局
未报告次要终点