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

NCT ID: NCT06668883

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 23 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-13
• Study Completion Date: 2025-05-21

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)

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Sputum collection for molecular analysis

Sputum collection to be used with syndromic multiplex PCR testing

Intervention Type: PROCEDURE

Breath and cough collection for molecular analysis

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: collaborator

Avelo AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Basel

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

2024-01738

Identifier Type: -

Identifier Source: org_study_id