Tuberculosis Screening in Paraguayan Prisons

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.

Conditions

• Volatile Organic Compounds
• Radiography

Interventions

DEVICE

electronic nose device

electronic nose device will be tested as a triage instrument for tuberculosis in a high risk population

DEVICE

dig chest Xray with automated readings

software for tuberculosis detection on digital Chest Xray providing a probability score from 0-100

Sponsors & Collaborators

• European Union

  collaborator OTHER

• Instituto de Saude Publica da Universidade do Porto

  collaborator OTHER

• VHIR

  collaborator UNKNOWN

• University Medical Center Groningen

  collaborator OTHER

• Laboratorio central de salud publica, Paraguay

  collaborator UNKNOWN

• Instituto Nacional de Enfermedades Respiratorias y del Ambiente Juan Max Boetner

  collaborator UNKNOWN

• National TB program Paraguay

  collaborator UNKNOWN

• IICS Paraguay

  collaborator UNKNOWN

• Radboud University Medical Center

  lead OTHER

Principal Investigators

• Cecile Magis-Escurra, MD,PhD · Radboud University Medical Center

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-10-18

Primary Completion

2023-07-01

Completion

2023-12-01

Countries

• Paraguay