Novel Exhaled Breath Aerosol Collection Devices in Patients With Lower Respiratory Tract Infection - a Performance and Acceptability Study (AeroCAP)

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia; Lower Respiratory Tract Infection (LRTI)
• Intervention / Treatment: Procedure: Sputum collection for molecular analysis; Device: Breath and cough collection for molecular analysis

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 and older admitted to the hospital with a clinical diagnosis of lower respiratory tract infection.

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathogen Concordance	Overall percent agreement, negative percent agreement, and positive percent agreement between syndromic respiratory multiplex PCR results from breath samples and sputum samples.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of indeterminate breath results	Proportion of breath samples with invalid and/or indeterminate syndromic respiratory multiplex PCR results	6 months
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.	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.	2 days after sample collection

Collaborators and Investigators

• Sponsor: Avelo AG
• Collaborators: University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2024
• Primary Completion (Actual): May 21, 2025
• Study Completion (Actual): May 21, 2025

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): November 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Pneumonia; Respiratory Tract Infections; Infections; Communicable Diseases; Breath
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 2024-01738

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No