Respiratory Diseases Clinical Trial
— AEROPLEXOfficial title:
Exhaled Breath Aerosol for the Etiological Diagnosis of Respiratory Tract Infections: a Pilot Study
NCT number | NCT06229613 |
Other study ID # | AEROPLEX |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 15, 2023 |
Est. completion date | February 1, 2024 |
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).
Status | Recruiting |
Enrollment | 45 |
Est. completion date | February 1, 2024 |
Est. primary completion date | February 1, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Pregnancy - Samples collected after 3 days from symptom onset. - Antibiotic drug taken during the previous 3 days |
Country | Name | City | State |
---|---|---|---|
Italy | Emerging Bacterial Pathogens Unit | Milan |
Lead Sponsor | Collaborator |
---|---|
Ospedale San Raffaele |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the feasibility of XBAs collection and analysis (index test) using the molecular tests currently in use | 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. | 8 months |
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