Effectiveness of implementation of exhaled breath aerosol sampling to screen for respiratory infections in migrant populations

Effectiveness of implementation of exhaled breath aerosol sampling to screen for respiratory infections in migrant populations - BreathforDx-screening

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035695

Enrollment

1136

Registered

2024-12-16

Start date

2025-03-28

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

A15 A16 J22 J06

Interventions

Group 1: Participants will provide a breath sample using blowtube-based breath collection device. Samples will be tested for respiratory viruses and tuberculosis using multiplex molecular platforms.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Individuals hosted in migrant arrival centers. Able and willing to provide informed consent.

Exclusion criteria

Exclusion criteria: Individuals who have completed active TB treatment within the past 12 months. Individuals who are currently undergoing treatment for active or latent TB.

Design outcomes

Primary

Measure	Time frame
1. Acceptability and usability of exhaled breath aerosol (XBA) sampling for screening of TB and respiratory viruses: •Frequency of successfully completed tests with each device •Proportion of participants who find the device easy to use •Proportion of participants who would repeat the test if necessary in the future •Proportion of participants who would use one device over the other, none of the two, or both equally •Proportion of participants who would use one device over the other stratified by the presence of respiratory symptoms 2. Feasibility of XBA sampling for screening of TB and respiratory viruses: •Frequency of completed sampling that led to the collection of sample sufficient for the analysis •Frequency of detection of pathogen	—

Measure

Time frame

1. Acceptability and usability of exhaled breath aerosol (XBA) sampling for screening of TB and respiratory viruses: •Frequency of successfully completed tests with each device •Proportion of participants who find the device easy to use •Proportion of participants who would repeat the test if necessary in the future •Proportion of participants who would use one device over the other, none of the two, or both equally •Proportion of participants who would use one device over the other stratified by the presence of respiratory symptoms 2. Feasibility of XBA sampling for screening of TB and respiratory viruses: •Frequency of completed sampling that led to the collection of sample sufficient for the analysis •Frequency of detection of pathogen

—

Secondary

Measure	Time frame
1. Acceptability and usability of XBA sampling as a screening method compared to the standard of care screening method: • Proportion of participants who prefer XBA collection tools to sputum/swab-based screening 2. Overall concordance of pathogen detection between XBA sampling analysis and standard of care: • Concordance of positive and negative results of standard of care screening vs XBA collection-based screening in diagnosis of tuberculosis and respiratory viral infections	—

Measure

Time frame

1. Acceptability and usability of XBA sampling as a screening method compared to the standard of care screening method: • Proportion of participants who prefer XBA collection tools to sputum/swab-based screening 2. Overall concordance of pathogen detection between XBA sampling analysis and standard of care: • Concordance of positive and negative results of standard of care screening vs XBA collection-based screening in diagnosis of tuberculosis and respiratory viral infections

—

Countries

Germany, Italy

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: Jun 27, 2026