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Tuberculosis Screening in Paraguayan Prisons (Prinose)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04407325
Recruitment Status : Unknown
Verified April 2020 by Radboud University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 29, 2020
Last Update Posted : May 29, 2020
Sponsor:
Collaborators:
European Union
Instituto de Saude Publica da Universidade do Porto
VHIR
University Medical Center Groningen
Laboratorio central de salud publica, Paraguay
Instituto Nacional de Enfermedades Respiratorias y del Ambiente Juan Max Boetner
National TB program Paraguay
IICS Paraguay
Information provided by (Responsible Party):
Radboud University Medical Center

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.

Condition or disease Intervention/treatment Phase
Volatile Organic Compounds Radiography Device: electronic nose device Device: dig chest Xray with automated readings Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: outcomes of individual smell prints and digital ChestXrays will be compared with sputum sampling for GenXpert and Mycobacterial culture
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Tuberculosis Screening With AeoNose and CAD4TB in Paraguayan Prisons
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis X-Rays

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 Name: (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 Name: CAD4TB computed automated detection software




Primary Outcome Measures :
  1. Volatile organic compound signal as measured with the AeoNose™ [ Time Frame: Baseline/ change from baseline at 3 and 6 months ]
    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

  2. Tuberculosis probablity score using Computed Automated detection software CAD4TB® on chest Xrays [ Time Frame: Baseline/ change from baseline at 3 and 6 months ]
    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.

  3. Positive mycobacterial sputum test [ Time Frame: Baseline/ change from baseline at 3 and 6 months ]
    positive GenXpert test and/or mycobacterial cultures are used to establish Tuberculosis diagnosis


Secondary Outcome Measures :
  1. Comparison of predictive value of volatile organic compound signal with Tuberculosis Probability Score [ Time Frame: Baseline/ change from baseline at 3 and 6 months ]
    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

  2. added value of the use of AeoNose and Cad4TB as a TB screening algorithm in vulnerable populations [ Time Frame: Baseline/ change from baseline at 3 and 6 months ]
    evaluation of the combined use of both AeoNose and Cad4TB probability score to predict active TB



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04407325


Contacts
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Contact: Luis Gomez Pacielo, MD +595961889657 luis.gomez@RadboudUMC.nl
Contact: Zita Swaders, Msc +31627512069 zita.swaders@RadboudUMC.nl

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

Documents provided by Radboud University Medical Center:
Study Protocol  [PDF] December 12, 2019
Informed Consent Form  [PDF] December 1, 2019

Additional Information:
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Responsible Party: Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT04407325    
Other Study ID Numbers: 823890-EUSAT-RCS
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University Medical Center:
tuberculosis
vulnerable populations
screening algorithms
cost effectiveness
neural networks
artificial intelligence
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections