Diagnostic accuracy and feasibility of EXhaled Breath Aerosol (XBA) sampling for detection of respiratory PATHogens in symptomatic patients (B-Path symptomatic)

Diagnostic accuracy and feasibility of EXhaled Breath Aerosol (XBA) sampling for detection of respiratory PATHogens in symptomatic patients (B-Path symptomatic) - B-Path symptomatic

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039074

Enrollment

960

Registered

2026-01-28

Start date

2026-02-01

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

J22 J06

Interventions

Group 1: Participants will provide one nasal/nasopharyngeal swab and a breath sample using a mask-based breath collection device. Samples will be tested for respiratory pathogens using multiplex molec

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients will be included for the first objective of the study if they meet the following criteria: • adults (=18 years of age) seeking care for respiratory symptoms at ambulatory clinic or emergency department sites • Symptoms of an Acute Respiratory Infection (ARI) (e.g., cough, fever, shortness of breath, sore throat, coryza, rhinorrhoea) • Able and willing to provide informed consent For the secondary objectives, additional inclusion criteria are: • Healthcare workers or related stakeholders for the respiratory diagnosis process • Patients enrolled in the main study who have used the face mask sampling device in this study • Provide consent to being interviewed and recorded

Exclusion criteria

Exclusion criteria: • Unable or unwilling to provide any reference standard samples (NPS) • ARI symptoms lasting >10 days • Unable or unwilling to provide informed consent

Design outcomes

Primary

Measure	Time frame
The primary objective of this study is to assess the diagnostic accuracy (sensitivity and specificity, yield) of the exhaled breath aerosol (XBA) face mask sampling (FMS) coupled with multiplex molecular testing for the diagnosis of respiratory infections compared to standard care.	—

Secondary

Measure	Time frame
The study has the following secondary objectives: 1. To assess the diagnostic yield of XBA sampling 2. To compare the clinical performance (accuracy and yield) of XBA sampling with comparator testing in intended use settings for diagnosing respiratory tract infection 3. To evaluate feasibility, acceptability and usability of XBA FMS for testing adults symptomatic for respiratory infection 4. To identify barriers to the adoption and integration of the XBA sampling devices into routine care 5. To explore feasibility of self-sampling with FMS and self-testing using a lateral-flow assay (sub-study) 6. To explore feasibility of metagenomics using XBA samples for pathogen detection	—

Measure

Time frame

The study has the following secondary objectives: 1. To assess the diagnostic yield of XBA sampling 2. To compare the clinical performance (accuracy and yield) of XBA sampling with comparator testing in intended use settings for diagnosing respiratory tract infection 3. To evaluate feasibility, acceptability and usability of XBA FMS for testing adults symptomatic for respiratory infection 4. To identify barriers to the adoption and integration of the XBA sampling devices into routine care 5. To explore feasibility of self-sampling with FMS and self-testing using a lateral-flow assay (sub-study) 6. To explore feasibility of metagenomics using XBA samples for pathogen detection

—

Countries

Germany, Italy, Romania

Contacts

Public ContactClaudia Denkinger

University Hospital Heidelberg

claudia.denkinger@uni-heidelberg.de+49 6221 56-22999

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026