NCT05399615撤回不适用
Detection of Bacterial and Viral Pathogens Infection Among Hospitalized Patients Feasibility Study
Scentech Medical Technologies Ltd2 个研究点 分布在 1 个国家开始时间: 2022年12月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Discovery of exhaled breath biomarkers
研究概览
简要总结
Detection of bacterial and viral pathogens infection among hospitalized patients using breath analysis - feasibility study.
详细描述
A diagnostic prospective single-site study, with no anticipated risks or constraints.
Primary objective: To identify a set of breath Volatile Organic Compound biomarkers that enable the detection of pathogens infection and inflammatory response to pathogens infection among hospitalized patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 80 years at the time of consent
- •Capable of understanding written and/or spoken language
- •Able to provide informed consent
- •Negative results for SARS-CoV-2
- •Diagnosed with suspected respiratory infection
排除标准
- •Under guardianship or deprived of liberty
- •Pregnant or lactating woman
- •Not able to breathe through mask for 8 minutes
- •Intubated patients
- •Patients in critical condition
- •Diagnosed with hospital-acquired infection
- •Medical history of malignancies
结局指标
主要结局
Discovery of exhaled breath biomarkers
时间窗: Through the study completion, up to 3 months.
To evaluate the sensitivity, specificity, positive and negative predictive value of metabolomic biomarkers in exhaled breath samples as compared with pathogens biomarkers found in participants' blood and sputum samples.
次要结局
- The association of exhaled biomarkers with inflammatory known biomarkers.(Through the study completion, up to 3 months.)
研究者
研究点 (2)
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