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

NCT06229613 | Completed

• 1 other identifier: AEROPLEX
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Respiratory Diseases

Keywords

respiratory infection; exhaled breath aerosols (XBAs); XBA collection devices

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

medical device for exhaled breath aerosols (XBAs) collection DEVICE

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ospedale San Raffaele: lead

Study Sites (1)

Emerging Bacterial Pathogens Unit

Milan, Italy, 20132, Italy

Location

MeSH Terms

Conditions

Respiratory Tract Diseases; Respiratory Tract Infections

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Infections

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Emerging Bacterial Pathogens, IRCCS San Raffaele Scientific Institute

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 29, 2024
• Study Start: May 15, 2023
• Primary Completion: February 1, 2024
• Study Completion: December 12, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

IT (1)