NCT04407325

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

October 18, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

1.7 years

First QC Date

April 23, 2020

Last Update Submit

March 30, 2023

Conditions

Volatile Organic CompoundsRadiography

Keywords

tuberculosisvulnerable populationsscreening algorithmscost effectivenessneural networksartificial intelligence

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Comparison of predictive value of volatile organic compound signal with Tuberculosis Probability Score

    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

    Baseline/ change from baseline at 3 and 6 months

Study Arms (1)

AeoNose

EXPERIMENTAL

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

Device: electronic nose deviceDevice: dig chest Xray with automated readings

Interventions

electronic nose deviceDEVICE

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

Also known as: (AeoNose, The eNose Company, the Netherlands)
AeoNose
dig chest Xray with automated readingsDEVICE

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

Also known as: CAD4TB computed automated detection software
AeoNose

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • A potential participant who meets any of the following criteria will be excluded from participation in this study:
  • Unable to exhale breath through the AeoNose™ during five minutes due to respiratory insufficiency
  • Unable to stand in an upright position for the CXR
  • Unable to communicate and comply with the instructions of the study team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Buen Pastor

Asuncion, Central Department, Paraguay

RECRUITING

UPI

Asuncion, Central Department, Paraguay

COMPLETED

Related Links

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Cecile Magis-Escurra, MD,PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Gomez Pacielo, MD

CONTACT

+595961889657luis.gomez@RadboudUMC.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: outcomes of individual smell prints and digital ChestXrays will be compared with sputum sampling for GenXpert and Mycobacterial culture
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2020

First Posted

May 29, 2020

Study Start

October 18, 2021

Primary Completion

July 1, 2023

Study Completion

December 1, 2023

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(2)