Radiography Clinical Trial
— PrinoseOfficial title:
Tuberculosis Screening With AeoNose and CAD4TB in Paraguayan Prisons
Two diagnostic tools for TB screening in high risk groups need additional assessment: the AeoNose™, an 'electronic nose device' for breath sampling, and digital chest X-ray (CXR) with computer aided detection with CAD4TB® software. This study will systematically screen prisoners and its' employees for TB, test the diagnostic performance of AeoNose™ and CAD4TB (both individually and together) as a TB screening tool and and establish Mycobacterium tuberculosis epidemiology in Paraguayan prisons.
Status | Recruiting |
Enrollment | 5000 |
Est. completion date | December 1, 2023 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - All persons, either being a prisoner or employee, of the involved penal institutions after providing informed consent, including those with known active TB disease and/or currently on TB treatment Exclusion Criteria: - A potential participant who meets any of the following criteria will be excluded from participation in this study: 1. Unable to exhale breath through the AeoNose™ during five minutes due to respiratory insufficiency 2. Unable to stand in an upright position for the CXR 3. Unable to communicate and comply with the instructions of the study team |
Country | Name | City | State |
---|---|---|---|
Paraguay | Buen Pastor | Asuncion | Central |
Paraguay | UPI | Asuncion | Central |
Lead Sponsor | Collaborator |
---|---|
Radboud University Medical Center | European Union, IICS Paraguay, Instituto de Saude Publica da Universidade do Porto, Instituto Nacional de Enfermedades Respiratorias y del Ambiente Juan Max Boetner, Laboratorio central de salud publica, Paraguay, National TB program Paraguay, University Medical Center Groningen, VHIR |
Paraguay,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Volatile organic compound signal as measured with the AeoNose™ | The exhaled breath 'smell print' of each participant will be compared over time at baseline, 3 months and 6 months with sputum microbiology results and digital Chest Xray to establish sensitivity and specificity of electronic nose signal to diagnose Tuberculosis | Baseline/ change from baseline at 3 and 6 months | |
Primary | Tuberculosis probablity score using Computed Automated detection software CAD4TB® on chest Xrays | Ranges from 0 to 100, where 0 would mean the lowest probability of having Tuberculosis and 100 would be the highest probability of having Tuberculosis. | Baseline/ change from baseline at 3 and 6 months | |
Primary | Positive mycobacterial sputum test | positive GenXpert test and/or mycobacterial cultures are used to establish Tuberculosis diagnosis | Baseline/ change from baseline at 3 and 6 months | |
Secondary | Comparison of predictive value of volatile organic compound signal with Tuberculosis Probability Score | comparison of correct positive predictions for active TB, with AeoNose (positive/ negative test result) and Cad4TB software from chest Xrays providing probability scores from 0-100 points | Baseline/ change from baseline at 3 and 6 months | |
Secondary | added value of the use of AeoNose and Cad4TB as a TB screening algorithm in vulnerable populations | evaluation of the combined use of both AeoNose and Cad4TB probability score to predict active TB | Baseline/ change from baseline at 3 and 6 months |
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