eNose-TB: Electronic Nose for Tuberculosis Screening

NCT04567498 | Active Not Recruiting

• 1 other identifier: 002/2019
• Study Type: interventional
• Target: 1,778
• Locations: 1 country
• Sites: 3

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.

Conditions

Tuberculosis

Keywords

electronic-nose; breath test; tuberculosis; screening; gender; remote area

Outcome Measures

Primary Outcomes (2)

• Diagnostic accuracy of electronic nose signal in screening tuberculosis that is measured through sensitivity, specificity, PPV, NPV

  sensitivity, specificity, positive predictive value, negative predictive value of e-nose signal in diagnosing TB, factors influencing the diagnostic accuracy

  2 years

• Access barriers, measured through questionnaire, interview, and focus group discussion

  access barriers to the TB screening that are measured through questionnaire, interview, and focus group discussion

  2 years

Secondary Outcomes (1)

• Time of a screening algorithm with eNose-TB, measured in days

  2 years

Study Arms (1)

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

EXPERIMENTAL

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)

Other: exhaled breath sampling

Interventions

exhaled breath sampling 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.

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

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Invalid measurements of breath tests
• Incomplete CXR data
• Missing specimens
• Unable to breath normally for 2 minutes due to respiratory illness

Sponsors & Collaborators

• Gadjah Mada University: lead

Study Sites (3)

Balai Kesehatan Masyarakat Klaten

Klaten, Central Java, 50131, Indonesia

Location

Primary health centers and hospital

Timika, Special Region of Papua, Indonesia

Location

Primary health centers and hospital

Yogyakarta, Special Region of Yogyakarta, Indonesia

Location

Related Publications (1)

• 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.

  PMID: 33882070 DERIVED

MeSH Terms

Conditions

Tuberculosis; Coitus

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexual Behavior; Behavior

Study Officials

• Antonia Saktiawati, MD, PhD

  Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

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

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 28, 2020
• Study Start: December 2, 2021
• Primary Completion: February 28, 2023
• Study Completion: December 31, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (3)