Clinical trial NCT04407325: Tuberculosis Screening in Paraguayan Prisons
Official title: Tuberculosis Screening With AeoNose and CAD4TB in Paraguayan Prisons
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Volatile Organic Compounds
Radiography
Keywords: tuberculosis
vulnerable populations
screening algorithms
cost effectiveness
neural networks
artificial intelligence
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: European Union
name: Instituto de Saude Publica da Universidade do Porto
name: VHIR
name: University Medical Center Groningen
name: Laboratorio central de salud publica, Paraguay
name: Instituto Nacional de Enfermedades Respiratorias y del Ambiente Juan Max Boetner
name: National TB program Paraguay
name: IICS Paraguay
First posted: 2020-05-29
Enrollment: 5000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: outcomes of individual smell prints and digital ChestXrays will be compared with sputum sampling for GenXpert and Mycobacterial culture
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: The aim of the World Health Organization (WHO) "End TB Strategy" is to end the global pandemic by 2035. To be able to succeed, better point-of-care (POC) tests are urgently needed to improve screening of high-risk populations. Prisons are recognized worldwide as high risk environments for the concentration, amplification and transmission of TB among prisoners and their communities outside. Paraguayan penal institutions are known to have very high incidence rates of active TB (3000-5000/100.000, according to Paraguayan Ministry of Justice). Two diagnostic tools for TB screening in high risk groups will be evaluated: 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® and assess prison Mycobacterium tuberculosis epidemiology through several objectives: Objective: 1. Assessment of the sensitivity and specificity of the AeoNose™ and its utility for mass TB screening in high incidence settings. 2. Evaluation of the feasibility and utility of CAD4TB® digital CXR as a mass screening tool for TB. 3. Identification of factors that affect diagnostic accuracy of AeoNose™ and CAD4TB®. 4. Assessment of TB epidemiology in Paraguayan prisons and identification of mycobacterial strains.

Study design: Diagnostic cohort study. Study population: Detainees (PPL) of Paraguayan penal institutions as well as their employees. Nature and extent of the burden and risks associated with participation, benefit and group relatedness.

Individual burden: all participants will perform one visit with a medical doctor for medical history, physical exam, digital X-ray (with CAD4TB®) and AeoNose sampling. Participants will be offered voluntary HIV testing and counseling. In case of presumptive TB (estimated 20-30% of participants) two sputum samples will be taken, either spontaneous or saline-induced. One sample is tested with GeneXpert and the other with liquid mycobacterial culture. Cases of presumptive TB with both negative GeneXpert® and culture results will be followed-up after three and six months for repeat testing.

Eligibility criteria: 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

Primary outcomes:
measure: Volatile organic compound signal as measured with the AeoNose™
timeFrame: Baseline/ change from baseline at 3 and 6 months
measure: Tuberculosis probablity score using Computed Automated detection software CAD4TB® on chest Xrays
timeFrame: Baseline/ change from baseline at 3 and 6 months
measure: Positive mycobacterial sputum test
timeFrame: Baseline/ change from baseline at 3 and 6 months
Secondary outcomes:
measure: Comparison of predictive value of volatile organic compound signal with Tuberculosis Probability Score
timeFrame: Baseline/ change from baseline at 3 and 6 months
measure: added value of the use of AeoNose and Cad4TB as a TB screening algorithm in vulnerable populations
timeFrame: Baseline/ change from baseline at 3 and 6 months
Other outcomes:
Locations:
city: Asuncion
country: Paraguay
facility: Buen Pastor
state: Central
city: Asuncion
country: Paraguay
facility: UPI
state: Central
Study officials:
affiliation: Radboud University Medical Center
name: Cecile Magis-Escurra, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: