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

NCT06668883 | Completed

• 1 other identifier: 2024-01738
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pneumonia; Lower Respiratory Tract Infection (LRTI)

Keywords

Respiratory Tract Infections; Pneumonia; Communicable Diseases; Infections; Breath

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Usability

  2 days after sample collection

• Expanded user feedback

  2 days after sample collection

• Rates of indeterminate breath results

  6 months

Interventions

Sputum collection for molecular analysis PROCEDURE

Sputum collection to be used with syndromic multiplex PCR testing

Breath and cough collection for molecular analysis DEVICE

Breath and cough collection with two proprietary devices to be used with syndromic multiplex PCR testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Avelo AG: lead
• University Hospital, Basel, Switzerland: collaborator

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Pneumonia; Respiratory Tract Infections; Communicable Diseases; Infections

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 1, 2024
• Study Start: November 13, 2024
• Primary Completion: May 21, 2025
• Study Completion: May 21, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

CH (1)