NCT06668883已完成不适用
Novel Exhaled Breath Aerosol Collection Devices in Patients With Lower Respiratory Tract Infection - a Performance and Acceptability Study (Acronym: AeroCAP)
Avelo AG1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2024年11月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Pathogen Concordance
研究概览
简要总结
This study will assess the performance of two novel breath collection devices and their subsequent detection of respiratory pathogens compared to sputum samples in patients with lower respiratory tract infections.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Able to understand the scope of the study and provide written informed consent
- •Age >18 years
- •Speaking German or English
- •Health status (assessed by study personnel at local site) well enough to use the breath collection devices
- •Willing to provide all three study samples (sputum and two breath samples) required for the study
- •Clinical diagnosis of a lower respiratory tract infection (LRTI) defined as:
- •(i) New infiltrate (chest X-ray, ultrasound, or CT scan), and (ii) at least one clinical symptom suggestive of LRTI (fever ≥38°C, chills, new or worsening cough, new or worsening sputum production, new or worsening dyspnea, tachypnoea, chest pain)
排除标准
- •Patients for whom the collection of all three study specimens within 48 hours of initiating antibiotic treatment is not feasible
- •Patients with known cystic fibrosis or bronchiectasis
- •Critically ill patients at the discretion of the investigator
- •Patients on oxygen supplementation with a face mask, high-flow-oxygen, non-invasive or mechanical ventilation; oxygen supplementation via nasal cannula will be permitted.
- •Patients with proven acute pulmonary embolism
- •Patients with best supportive care
- •Patients with severe hypoxemia (SpO2 <88%) despite oxygen supplementation
- •Hospitalization within the last 14 days prior to admission
结局指标
主要结局
Pathogen Concordance
时间窗: 6 months
Overall percent agreement, negative percent agreement, and positive percent agreement between syndromic respiratory multiplex PCR results from breath samples and sputum samples.
次要结局
- Usability(2 days after sample collection)
- Expanded user feedback(2 days after sample collection)
- Rates of indeterminate breath results(6 months)
研究者
研究点 (1)
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