Exhaled Breath Aerosol for the Etiological Diagnosis of Respiratory Tract Infections: a Pilot Study (AEROPLEX)

Pilot study for the evaluation of the feasibility of pathogen detection in exhaled breath aerosols (XBAs) samples using the AveloCollect device.

The aim of the study is to evaluate the feasibility of XBA collection and molecular detection of respiratory pathogens using the AveloCollect BlowTube device (index test) in subjects with a clinical presentation consistent with a respiratory infectious disease, compared to the same molecular assays performed on nasopharyngeal secretions (using commercially available swabs) and sputum (comparator tests).

Study Overview

• Status: Completed
• Conditions: Respiratory Diseases
• Intervention / Treatment: Device: medical device for exhaled breath aerosols (XBAs) collection

Detailed Description

Respiratory infections have a significant impact in terms of morbidity and mortality, both in the EU and globally and were responsible for the majority of pandemics in the last centuries. Human breath is an attractive sample type, given the ease of sample collection via non-invasive methods, its direct link to the route of transmission, and its potential role as an indicator of infectiousness. In particular, recent studies have focused on the exhaled breath aerosols (XBAs). Aerosol transmission was demonstrated for many respiratory infections, including pandemic influenza, respiratory syncytial virus (RSV), tuberculosis (TB) and COVID-19. Pathogen detection in XBA samples has shown a good sensitivity, but currently available research tools are highly technical and resource demanding. New and simplified XBA collection devices (Face masks, AveloCollect Blow tube device) are currently under evaluation, and further clinical studies are needed in order to assess their feasibility for pathogen detection in clinical practice, especially for etiological diagnosis in patients with unspecific respiratory symptoms.

The objective of this study is to evaluate the feasibility of XBAs collection and analysis (index test) using the molecular tests currently in use at San Raffaele Hospital for the detection of respiratory pathogens in clinical samples, compared to upper respiratory secretion and sputum samples, that will be collected using standard procedures and analysed using the same kits (comparator tests).

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20132
    • Emerging Bacterial Pathogens Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Healthcare workers with fever, cough, sore throat, dyspnea, rhinitis and/or conjunctivitis will be enrolled

Description

Inclusion Criteria:

• Adult age (≥18 years)
• Subjects with one or more symptoms of respiratory tract infection (fever, cough, sore throat, dyspnea, conjunctivitis and/or rhinitis).
• Samples collected within 3 days from symptom onset.
• No antibiotic drug taken during the previous 3 days

Exclusion Criteria:

• Pregnancy
• Samples collected after 3 days from symptom onset.
• Antibiotic drug taken during the previous 3 days

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the feasibility of XBAs collection and analysis (index test) using the molecular tests currently in use	Descriptive analyses will be carried out. The samples will undergo molecular analysis in order to detect respiratory pathogens, using the tests currently in use at San Raffaele Hospital for detection of respiratory pathogens in clinical samples.	8 months

Collaborators and Investigators

• Sponsor: Ospedale San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): December 12, 2024

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: respiratory infection; exhaled breath aerosols (XBAs); XBA collection devices
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders
• Other Study ID Numbers: AEROPLEX

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No