eNose-TB: Electronic Nose for Tuberculosis Screening

Tuberculosis Clinical Trial

Official title:

eNose-TB: Electronic Nose for Tuberculosis Screening in Indonesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04567498
• Other study ID #: 002/2019
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: Gadjah Mada University
• Contact: Antonia Saktiawati, MD, PhD
• Phone: +6281227976434
• Email: a.morita[@]ugm.ac.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1778
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Tuberculosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Indonesia	Balai Kesehatan Masyarakat Klaten	Klaten	Central Java
Indonesia	Primary health centers	Yogyakarta

Sponsors (1)

Lead Sponsor	Collaborator
Gadjah Mada University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic accuracy of electronic nose signal in tuberculosis	sensitivity, specificity, positive predictive value, negative predictive value of e-nose signal in diagnosing TB	2 years