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

Recruiting

• Conditions: Pneumonia; Lower Respiratory Tract Infection (LRTI)

• Registration Number: NCT06668883
• Lead Sponsor: Avelo AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-29
• Study First Submitted QC: 2024-10-30
• Status Verified: 2024-11
• Study First Posted: 2024-11-01
• Study Start: 2024-11-13
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-18
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathogen Concordance	6 months	Overall percent agreement, negative percent agreement, and positive percent agreement between syndromic respiratory multiplex PCR results from breath samples and sputum samples.

Secondary Outcome Measures

Name	Time	Method
Usability	2 days after sample collection	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.
Expanded user feedback	2 days after sample collection	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.
Rates of indeterminate breath results	6 months	Proportion of breath samples with invalid and/or indeterminate syndromic respiratory multiplex PCR results

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland