Detection of Influenza or SARS-CoV-2 Infection by IMS of Nasal Air Sampling
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Cluster Analysis of MCC IMS spectra.
研究概览
简要总结
Multicapillary Ion mobility spectrometry of nasal air aspirates shall be investigated as screening tool for the detection of Influenza and SARS-CoV-2- infection.
详细描述
Bacterial infections can be distinguished by analysis of the volatile organic compounds found in breath.
In patients with suspected Influenza infection, nasal air samples will be taken and analyzed by Multicapillary Ion mobility spectrometry (MCC IMS). Routinely all patients undergo polymerase chain reaction (PCR) analysis of nasopharyngeal swabs for Influenza.
MCC IMS spectra will be compared between infected and non infected patients by cluster analysis and discrimination analysis.
If the number of infected patients exceeds 50 an additional validation cohort will be investigated sequentially otherwise validation will be performed during the Influenza epidemic 2021.
Due to decreasing numbers of Influenza-A- Infections study was opened to also include patients with suspected SARS-CoV-2 infections.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suspected Influenza infection
排除标准
- •later than 48h after admission and detection of Influenza infection
- •later than 32 days after admission and detection of SARS-CoV-2- infection
- •no written consent
结局指标
主要结局
Cluster Analysis of MCC IMS spectra.
时间窗: immediatly after sampling
Cluster Analysis of MCC IMS spectra will be obtained immediately after sampling
次要结局
未报告次要终点
研究者
Claus Steppert
Director Department of pulmonology and thoracic oncology
Klinikum Bayreuth GmbH