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Novel Exhaled Breath Aerosol Collection Devices in Patients With Lower Respiratory Tract Infection - a Performance and Acceptability Study | Clinical Trials | Clareo Health

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

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

NCT06668883•Avelo AG

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

University Hospital Basel

Basel, Switzerland

Key Dates

Start Date

November 13, 2024

Primary Completion Date

May 21, 2025

Completion Date

May 21, 2025

Last Updated

August 8, 2025

Enrollment

ACTUAL participants

Conditions

PneumoniaLower Respiratory Tract Infection (LRTI)

Interventions

Sputum collection for molecular analysis

PROCEDURE

Breath and cough collection for molecular analysis

DEVICE

Effect of Acetylcysteine Inhalation on Incidence and Time to Develop Ventilator Associated Pneumonia in Critically Ill Mechanically Ventilated Patients

NCT07409727

Ventilation Acquired Pneumonia

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RECRUITINGNA

Driving Pressure During Surgeries With High Risk for Postoperative Pulmonary Complications

NCT07186933

Postoperative Pulmonary AtelectasisPostoperative Pulmonary Complications+8 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Effect of Acetylcysteine Inhalation on Incidence and Time to Develop Ventilator Associated Pneumonia in Critically Ill Mechanically Ventilated Patients

Driving Pressure During Surgeries With High Risk for Postoperative Pulmonary Complications

Performance of New Diagnostic Methods in Older Adults With Pneumonia

Health Systems and Policy Contexts of Medical Oxygen

High PEEP in Noninvasive Ventilation Patients With Pneumonia or ARDS

Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure