Respiratory DiseasesAEROPLEXNCT06229613
Exhaled Breath Aerosol for the Etiological Diagnosis of Respiratory Tract Infections: a Pilot Study
An observational study of Respiratory Diseases, run by Ospedale San Raffaele at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Diseases
- What is being tested?
- medical device for exhaled breath aerosols (XBAs) collection
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2023to 12 Dec 2024
- How long will I take part?
- 5 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthcare workers with fever, cough, sore throat, dyspnea, rhinitis and/or conjunctivitis will be enrolled
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Samples collected after 3 days from symptom onset.
- Antibiotic drug taken during the previous 3 days
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
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).
- Conditions
- Respiratory Diseases
- Being tested
- medical device for exhaled breath aerosols (XBAs) collection
- Keywords
- respiratory infection, exhaled breath aerosols (XBAs), XBA collection devices
- Medical subject headings
- Respiratory Tract Diseases, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical device for exhaled breath aerosols (XBAs) collectionDevice
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start15 May 2023
- Primary completion1 Feb 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Maria Cirillo, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229613
- Sponsor's protocol ID
- AEROPLEX
- Acronym
- AEROPLEX
- Status last verified
- Feb 2025
- First submitted
- 22 Dec 2023
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Breath Aerosol for the Etiological Diagnosis of Respiratory Tract Infections: a Pilot Study
- ClinicalTrials.gov ID
- NCT06229613
- Acronym / sponsor ID
- AEROPLEX / AEROPLEX
- Conditions
- Respiratory Diseases
- Keywords
- respiratory infection, exhaled breath aerosols (XBAs), XBA collection devices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ospedale San RaffaeleUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare workers with fever, cough, sore throat, dyspnea, rhinitis and/or conjunctivitis will be enrolled
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy
- Samples collected after 3 days from symptom onset.
- Antibiotic drug taken during the previous 3 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical device for exhaled breath aerosols (XBAs) collectionTo 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). | Device | – |
Primary outcome
To evaluate the feasibility of XBAs collection and analysis (index test) using the molecular tests currently in use
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Diseases, run by Ospedale San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the feasibility of XBAs collection and analysis (index test) using the molecular tests currently in use (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.