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临床试验/NCT06229613
NCT06229613已完成不适用

Exhaled Breath Aerosol for the Etiological Diagnosis of Respiratory Tract Infections: a Pilot Study

Ospedale San Raffaele1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年5月15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
45
试验地点
1
主要终点
To evaluate the feasibility of XBAs collection and analysis (index test) using the molecular tests currently in use

研究概览

简要总结

Pilot study for the evaluation of the feasibility of pathogen detection in exhaled breath aerosols (XBAs) samples using the AveloCollect device.

The aim of the study is to evaluate the feasibility of XBA collection and molecular detection of respiratory pathogens using the AveloCollect BlowTube device (index test) in subjects with a clinical presentation consistent with a respiratory infectious disease, compared to the same molecular assays performed on nasopharyngeal secretions (using commercially available swabs) and sputum (comparator tests).

详细描述

Respiratory infections have a significant impact in terms of morbidity and mortality, both in the EU and globally and were responsible for the majority of pandemics in the last centuries. Human breath is an attractive sample type, given the ease of sample collection via non-invasive methods, its direct link to the route of transmission, and its potential role as an indicator of infectiousness. In particular, recent studies have focused on the exhaled breath aerosols (XBAs). Aerosol transmission was demonstrated for many respiratory infections, including pandemic influenza, respiratory syncytial virus (RSV), tuberculosis (TB) and COVID-19. Pathogen detection in XBA samples has shown a good sensitivity, but currently available research tools are highly technical and resource demanding. New and simplified XBA collection devices (Face masks, AveloCollect Blow tube device) are currently under evaluation, and further clinical studies are needed in order to assess their feasibility for pathogen detection in clinical practice, especially for etiological diagnosis in patients with unspecific respiratory symptoms.

The objective of this study is to evaluate the feasibility of XBAs collection and analysis (index test) using the molecular tests currently in use at San Raffaele Hospital for the detection of respiratory pathogens in clinical samples, compared to upper respiratory secretion and sputum samples, that will be collected using standard procedures and analysed using the same kits (comparator tests).

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

入选标准

  • Adult age (≥18 years)
  • Subjects with one or more symptoms of respiratory tract infection (fever, cough, sore throat, dyspnea, conjunctivitis and/or rhinitis).
  • Samples collected within 3 days from symptom onset.
  • No antibiotic drug taken during the previous 3 days

排除标准

  • Pregnancy
  • Samples collected after 3 days from symptom onset.
  • Antibiotic drug taken during the previous 3 days

结局指标

主要结局

To evaluate the feasibility of XBAs collection and analysis (index test) using the molecular tests currently in use

时间窗: 8 months

Descriptive analyses will be carried out. The samples will undergo molecular analysis in order to detect respiratory pathogens, using the tests currently in use at San Raffaele Hospital for detection of respiratory pathogens in clinical samples.

次要结局

未报告次要终点

研究者

发起方
Ospedale San Raffaele
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniela Maria Cirillo

Head Emerging Bacterial Pathogens, IRCCS San Raffaele Scientific Institute

IRCCS Ospedale San Raffaele

研究点 (1)

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