eNose-TB: Electronic Nose for Tuberculosis Screening

Gadjah Mada University

Status: Active, not recruiting

Conditions: Tuberculosis

Treatments: Other: exhaled breath sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT04567498

002/2019

Details and patient eligibility

About

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.

Full 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 (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.

Enrollment: 1,778 patients

Sex: All

Ages: 4+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,778 participants in 1 patient group

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

Experimental group

Description:

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)

Treatment:

Other: exhaled breath sampling