PneumoniaAeroCAPNCT06668883
Novel Exhaled Breath Aerosol Collection Devices in Patients With Lower Respiratory Tract Infection - a Performance and Acceptability Study
An observational study of Pneumonia and Lower Respiratory Tract Infection (LRTI), run by Avelo AG at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Lower Respiratory Tract Infection (LRTI)
- What is being tested?
- Sputum collection for molecular analysis and Breath and cough collection for molecular analysis
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Nov 2024to 21 May 2025
- 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: Adults aged 18 and older admitted to the hospital with a clinical diagnosis of lower respiratory tract infection.
Who may be able to join
- 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:
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Exhaled Breath Aerosol Collection Devices in Patients With Lower Respiratory Tract Infection - a Performance and Acceptability Study (Acronym: AeroCAP)
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.
- Being tested
- Sputum collection for molecular analysis, Breath and cough collection for molecular analysis
- Keywords
- Respiratory Tract Infections, Pneumonia, Communicable Diseases, Infections, Breath
- Medical subject headings
- Pneumonia, Respiratory Tract Infections, Communicable Diseases, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sputum collection for molecular analysisProcedure or surgery
Sputum collection to be used with syndromic multiplex PCR testing
Breath and cough collection for molecular analysisDevice
Breath and cough collection with two proprietary devices to be used with syndromic multiplex PCR testing
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathogen Concordance
Overall percent agreement, negative percent agreement, and positive percent agreement between syndromic respiratory multiplex PCR results from breath samples and sputum samples.
Measured: 6 months
Secondary outcomes (3)
Usability
Assess the usability of the breath collection devices and sampling procedures by gathering user feedback from patients using a multiple choice questionnaire. Ease-of-use questions will be assessed using a 5-point difficulty rating system. Additionally, the investigators will assess the proportion of participants able to complete the breath collections without any deviations.
Measured: 2 days after sample collection
Expanded user feedback
A subset of patients and clinicians will be observed during the breath collection process. The investigators will gather the proportion of participants making errors during breath collections and documenting any common difficulties.
User feedback data from a subset of patients and clinicians will be gathered via semi-structured interviews. Data will be assessed qualitatively for reported acceptability and user preferences.
Measured: 2 days after sample collection
Rates of indeterminate breath results
Proportion of breath samples with invalid and/or indeterminate syndromic respiratory multiplex PCR results
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start13 Nov 2024
- Primary completion21 May 2025
- Study completion21 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avelo AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Basel, Switzerland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668883
- Sponsor's protocol ID
- 2024-01738
- Acronym
- AeroCAP
- Status last verified
- Aug 2025
- First submitted
- 29 Oct 2024
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tiseo K, Drager S, Santhosh Kumar H, Alkhazashvili M, Hammann A, Risch P, Willi R, Mkhatvari T, Fialova C, Adlhart C, Szabo D, Suknidze M, Pachkoria I, Broger T, Ivanova Reipold E, Varshanidze K, Osthoff M. Breath aerosol PCR for detection of lower respiratory tract infections: evaluation of a non-invasive face mask collector in pneumonia patients. J Clin Microbiol. 2026 Sep 10:e0056226. doi: 10.1128/jcm.00562-26. Online ahead of print.
PubMed 42721424
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Exhaled Breath Aerosol Collection Devices in Patients With Lower Respiratory Tract Infection - a Performance and Acceptability Study (Acronym: AeroCAP)
- ClinicalTrials.gov ID
- NCT06668883
- Acronym / sponsor ID
- AeroCAP / 2024-01738
- Keywords
- Respiratory Tract Infections, Pneumonia, Communicable Diseases, Infections, Breath
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Avelo AGIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Basel, Switzerland
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 21 May 2025 (actual)
- Study completion
- 21 May 2025 (actual)
- First posted
- 1 Nov 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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 and older admitted to the hospital with a clinical diagnosis of lower respiratory tract infection.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Sputum collection for molecular analysisSputum collection to be used with syndromic multiplex PCR testing | Procedure or surgery | – |
| Breath and cough collection for molecular analysisBreath and cough collection with two proprietary devices to be used with syndromic multiplex PCR testing | Device | – |
Primary outcome
Pathogen Concordance
Time frame: 6 months
Overall percent agreement, negative percent agreement, and positive percent agreement between syndromic respiratory multiplex PCR results from breath samples and sputum samples.
3 secondary outcomes
Usability
Time frame: 2 days after sample collection
Expanded user feedback
Time frame: 2 days after sample collection
Rates of indeterminate breath results
Time frame: 6 months
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 8 Aug 2025.
- Derived from this study: PubMed 42721424Tiseo K, Drager S, Santhosh Kumar H, Alkhazashvili M, Hammann A, Risch P, Willi R, Mkhatvari T, Fialova C, Adlhart C, Szabo D, Suknidze M, Pachkoria I, Broger T, Ivanova Reipold E, Varshanidze K, Osthoff M. Breath aerosol PCR for detection of lower respiratory tract infections: evaluation of a non-invasive face mask collector in pneumonia patients. J Clin Microbiol. 2026 Sep 10:e0056226. doi: 10.1128/jcm.00562-26. Online ahead of print.
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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 Pneumonia and Lower Respiratory Tract Infection (LRTI), run by Avelo AG at 1 site in Switzerland.
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 7 inclusion and 8 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 8 Aug 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 Switzerland. 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?
Pathogen Concordance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06668883, which also lists 1 linked publication.
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 8 Aug 2025.