eNose-TB: Electronic Nose for Tuberculosis Screening

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

1778 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-02

Study Completion Date

2024-12-31

Brief Summary

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An electronic-nose (e-nose) is being 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 particularly in remote area. Various factors (gender, age, race, and location) are considered in the algorithm training to develop an inclusive eNose. Access barriers, especially those faced by women, are also assessed.

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Detailed Description

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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 (two times). 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.

Demographic (gender, age, race, and location) and clinical data (symptoms, physical examination, laboratory examinations) are collected. Access barriers, especially for women, are also assessed through questionnaire and interviews.

Conditions

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Tuberculosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The Validation phase involves presumptive TB patients (Group 1) and the Screening phase involves residents of area with high risk of TB (Group 2)

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

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.

Study Groups

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Presumptive TB patients and residents of area with high risk of TB

Presumptive TB patients consists of 395 participants - adult and children, while Residents of area with high risk of TB consists of 1383 participants - adult and children)

Group Type EXPERIMENTAL

exhaled breath sampling

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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