eNose-TB: Electronic Nose for Tuberculosis Screening

Sponsor

Gadjah Mada University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04567498

Collaborator

(none)

1,778

Enrollment

Locations

Arms

12.9

Anticipated Duration (Months)

889

Patients Per Site

68.7

Patients Per Site Per Month

Study Details

Study Description

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 Other: exhaled breath sampling	N/A

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 (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.

Study Design

Study Type:

Interventional

Anticipated 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)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

Actual Study Start Date :

Dec 2, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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 Names: 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 Names: GeNose exhaled breath sampling

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 Names:

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

Other Names:

GeNose exhaled breath sampling

Outcome Measures

Primary Outcome Measures

diagnostic accuracy of electronic nose signal in tuberculosis [2 years]
sensitivity, specificity, positive predictive value, negative predictive value of e-nose signal in diagnosing TB

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Balai Kesehatan Masyarakat Klaten	Klaten	Central Java	Indonesia	50131
2	Primary health centers	Yogyakarta		Indonesia

Sponsors and Collaborators

Gadjah Mada University

Investigators

Principal Investigator: Yodi Mahendradhata, MD, MSc, PhD, Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada
Principal Investigator: Antonia Saktiawati, MD, PhD, Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada