Clinical trial NCT04567498: eNose-TB: Electronic Nose for Tuberculosis Screening
Official title: eNose-TB: Electronic Nose for Tuberculosis Screening in Indonesia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tuberculosis
Keywords: electronic-nose
breath test
tuberculosis
screening
gender
remote area
Lead sponsor: Gadjah Mada University
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 1778
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: SCREENING

Brief summary: 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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Diagnostic accuracy of electronic nose signal in screening tuberculosis that is measured through sensitivity, specificity, PPV, NPV
timeFrame: 2 years
measure: Access barriers, measured through questionnaire, interview, and focus group discussion
timeFrame: 2 years
Secondary outcomes:
measure: Time of a screening algorithm with eNose-TB, measured in days
timeFrame: 2 years
Other outcomes:
Locations:
city: Klaten
country: Indonesia
facility: Balai Kesehatan Masyarakat Klaten
state: Central Java
city: Yogyakarta
country: Indonesia
facility: Primary health centers and hospital
state: Daerah Istimewa Yogyakarta
city: Timika
country: Indonesia
facility: Primary health centers and hospital
state: Papua
Study officials:
affiliation: Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada
name: Antonia Saktiawati, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saktiawati AMI, Triyana K, Wahyuningtias SD, Dwihardiani B, Julian T, Hidayat SN, Ahmad RA, Probandari A, Mahendradhata Y. eNose-TB: A trial study protocol of electronic nose for tuberculosis screening in Indonesia. PLoS One. 2021 Apr 21;16(4):e0249689. doi: 10.1371/journal.pone.0249689. eCollection 2021.