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

Respiratory Diseases Clinical Trial

— AEROPLEX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06229613
• Other study ID #: AEROPLEX
• Status: Recruiting
• Start date: May 15, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: December 2023
• Source: Ospedale San Raffaele
• Contact: Daniela M Cirillo, MD,PhD
• Phone: +39 02.2643.5685
• Email: cirillo.daniela[@]hsr.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Respiration Disorders
• Respiratory Diseases
• Respiratory Tract Diseases
• Respiratory Tract Infections

Intervention

Device:
• medical device for exhaled breath aerosols (XBAs) collection
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).

Locations

Country	Name	City	State
Italy	Emerging Bacterial Pathogens Unit	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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