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eNose-TB: Electronic Nose for Tuberculosis Screening

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04567498
Recruitment Status : Not yet recruiting
First Posted : September 28, 2020
Last Update Posted : November 23, 2020
Sponsor:
Information provided by (Responsible Party):
dr.Yodi Mahendradhata, M.Sc, Ph.D, FRSPH, Gadjah Mada University

Study Description
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Brief Summary:
An electronic-nose (e-nose) had been investigated as a diagnostic tool for tuberculosis by examining exhaled breath of the patients. Universitas Gadjah Mada has developed an e-nose device for TB diagnostic tool. Here the investigators test the device in order to analyze the sensitivity and specificity electronic-nose as a screening tool for tuberculosis.

Condition or disease Intervention/treatment Phase
Tuberculosis Other: exhaled breath sampling Not Applicable

Detailed Description:

The study population consists of 2 groups:

Group 1 - presumptive TB patients. Group 2 - residents of area with high risk of TB.

Study participants provide written informed consent. The participants are asked to breathe normally using a mask for 2 times then inhale and exhale in a forced expiratory volume to the air collecting bag until the collecting bag is full. The collecting bag is sealed and connected to the e-nose machine via a collecting hose and HEPA-filter protecting the e-nose from microbes. The breath pattern will be recorded in the e-nose device, which is connected to a laptop that will display the recorded breath pattern. Other data are collected: clinical symptoms, results of chest X-ray, smear microscopic, and Xpert MTB/Rif examinations.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1778 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: The Validation phase involves suspected TB patients (Group 1) and the Screening phase involves residents of area with high risk of TB (Group 2)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The study use a triple-blind masking, in which the research subjects, breath sample takers, and laboratory sample examiners do not know the results of each sampling that has been done. The final data processor is also blinded to the results of Xpert or other laboratory examinations. The breath sampling data is saved in graphic form which interpretation will be carried out later by the data processor at the final stage.
Primary Purpose: Screening
Official Title: eNose-TB: Electronic Nose for Tuberculosis Screening in Indonesia
Estimated Study Start Date : November 20, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Presumptive TB patients (395 participants - adult and children)
The participants breathe normally using a mask for 2 times then they are asked to inhale and exhale in a forced expiratory volume to the air collecting bag until the collecting bag is full.
 Other: exhaled breath sampling
The participants are requested to quietly sit and breathe to the air collecting bag until the collecting bag is full. The collecting bag is sealed and connected to the e-nose machine via a collecting hose and HEPA-filter. The data are read and stored in the e-nose machine.
Other Name: GeNose exhaled breath sampling
Experimental: Residents of area with high risk of TB (1383 participants - adult and children)
The participants breathe normally using a mask for 2 times then they are asked to inhale and exhale in a forced expiratory volume to the air collecting bag until the collecting bag is full.
 Other: exhaled breath sampling
The participants are requested to quietly sit and breathe to the air collecting bag until the collecting bag is full. The collecting bag is sealed and connected to the e-nose machine via a collecting hose and HEPA-filter. The data are read and stored in the e-nose machine.
Other Name: GeNose exhaled breath sampling


Outcome Measures
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Primary Outcome Measures :
  1. diagnostic accuracy of electronic nose signal in tuberculosis [ Time Frame: 2 years ]
    sensitivity, specificity, positive predictive value, negative predictive value of e-nose signal in diagnosing TB


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

- Inclusion Criteria:

Validation Phase (Group 1):

  • Adult and children
  • Suspected of having TB
  • Agree to participate in the study
  • Able to produce exhaled air samples
  • Able to produce samples for Xpert MTB/Rif examination

Screening Phase (Group 2):

  • Adult and children
  • Agree to participate in the study
  • Able to produce exhaled air samples

  • Currently not in TB treatment

    - Exclusion Criteria

  • Invalid measurements of breath tests
  • Incomplete CXR data
  • Missing specimens
  • Unable to breath normally for 2 minutes due to respiratory illness
Contacts and Locations
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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): NCT04567498


Contacts
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Contact: Yodi Mahendradhata, MD, MSc, Ph.D, +6281294713613 yodi_mahendradhata@yahoo.co.uk

Locations
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Indonesia
Surakarta Central General Hospital
Surakarta, Central Java, Indonesia, 57144
Contact: Firdaufan, SKM, M.Kes    6281393391969      
Primary health centers
Yogyakarta, Indonesia
Contact: Suharna    +628156898290      
Sponsors and Collaborators
Gadjah Mada University
Investigators
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Principal Investigator: Yodi Mahendradhata, MD, MSc, PhD Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: dr.Yodi Mahendradhata, M.Sc, Ph.D, FRSPH, Vice Dean for Research and Development, Gadjah Mada University
ClinicalTrials.gov Identifier: NCT04567498    
Other Study ID Numbers: 002/2019
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: November 23, 2020
Last Verified: November 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 dr.Yodi Mahendradhata, M.Sc, Ph.D, FRSPH, Gadjah Mada University:
electronic-nose
breath test
tuberculosis
screening
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
 Bacterial Infections
Bacterial Infections and Mycoses
Infections