Tuberculosis Screening in Paraguayan Prisons (Prinose)

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.

Study Overview

• Status: Recruiting
• Conditions: Radiography; Volatile Organic Compounds
• Intervention / Treatment: Device: electronic nose device; Device: dig chest Xray with automated readings

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.

• Study Type: Interventional
• Enrollment (Anticipated): 5000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luis Gomez Pacielo, MD; Phone Number: +595961889657; Email: luis.gomez@RadboudUMC.nl

Study Locations

• Paraguay
  • Central
    • Asuncion, Central, Paraguay
      • Recruiting
      • Buen Pastor
      • Contact: Claudia Pinanez, MD; Email: claupinanez@hotmail.com
    • Asuncion, Central, Paraguay
      • Completed
      • UPI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: AeoNose; the AeoNose will be compared with digital ChestXray and the conventional methods of establishing TB diagnosis

Device: electronic nose device; electronic nose device will be tested as a triage instrument for tuberculosis in a high risk population; Other Names: (AeoNose, The eNose Company, the Netherlands); Device: dig chest Xray with automated readings; software for tuberculosis detection on digital Chest Xray providing a probability score from 0-100; Other Names: CAD4TB computed automated detection software

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: University Medical Center Groningen; European Union; Instituto de Saude Publica da Universidade do Porto; VHIR; Laboratorio central de salud publica, Paraguay; Instituto Nacional de Enfermedades Respiratorias y del Ambiente Juan Max Boetner; National TB program Paraguay; IICS Paraguay
• Investigators: Principal Investigator: Cecile Magis-Escurra, MD,PhD, Radboud University Medical Center

Publications and helpful links

Helpful Links

• EUSAT-RCS TB research consortium

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: May 25, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: artificial intelligence; tuberculosis; cost effectiveness; vulnerable populations; neural networks; screening algorithms
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: 823890-EUSAT-RCS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No