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

Avelo AG

Status: Enrolling

Conditions: Lower Respiratory Tract Infection (LRTI); Pneumonia

Treatments: Procedure: Sputum collection for molecular analysis; Device: Breath and cough collection for molecular analysis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06668883

2024-01738

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to understand the scope of the study and provide written informed consent

• Age >18 years

• Speaking German

• 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 24 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