ENOSE in Pulmonary Tuberculosis in Yogyakarta

The Accuracy of the eNose in the Diagnostics and Monitoring of Treatment of Treatment-naive TB Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02219945

Acronym

YOGYATBNOSE

Enrollment

389

Registered

2014-08-19

Start date

2013-11-30

Completion date

2017-04-30

Last updated

2017-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other Specified Chronic Obstructive Pulmonary Disease, Pulmonary Tuberculosis Suspected, Pulmonary Tuberculosis TB (+) Histology, (-) Bacteriology

Keywords

pulmonary tuberculosis; electronic nose; diagnostic accuracy

Brief summary

Electronic noses detecting patterns of volatile molecules have recently been introduced for different diagnostic purposes. The diagnostic accuracy of a prototype e-nose device (Bruins et al (2013) in Bangladesh showed sensitivity of 76.5-95.9% and specificity of 85.3-98.5%. Here the investigators test a production type point-of-care hand-held device with less detectors. The investigators explore factors such as food intake, smoking, and co-morbidity, as well as the impact of TB treatment, and address the question whether the device could help monitor disease and response to treatment.

Detailed description

Study participants provide WIC and after time for consideration, when they approve, provide demographic anonymized data. The study population consists of six groups: Group 1 - 20 TB patients aged \> 18 yrs Group 2 - 20 non---TB patients \> 18 yrs (screened for TB - other conditions) Group 3 - 20 patients with a lung disease - no TB suspects (Lung Clinics in Yogyakarta,Indonesia; Group 4 - 50 apparently healthy matched controls Group 5 - 20 newly diagnosed TB patients enrolled before start of treatment, to be followed over time, until after end of treatment (8 months FU). Group 6 - 50 apparently healthy volunteers. Study participants breath normally by mouthpiece into the device using a nose clamp - for 5 min during each sampling. Electronic data are downloaded and transmitted by internet to Zutphen, Netherlands where data are processed to build the model.

Interventions

OTHER5 min exhaled breath sampling with soft nose clamp

study participants are requested to quietly sit and allow exhaled breath to be sampled through mouth piece breathing with nose clamp during 5 min while electronic data are collected in the device and later downloaded on a laptop pc

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

6 groups: 1\) 20 TB patients 2) 20 non-TB patients (alternative diagnosis) 3) 20 patients with chest symptoms - non-TB 4) 7 MDR-TB patients 5) 20 healthy controls 6) 300 subjects suspected to have pulmonary tuberculosis - follow-up for 2.5 years

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* age \>18yrs * voluntarily participating

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
diagnostic precision of electronic nose signal in pulmonary TB	18 months	sensitivity and specificity of electronic nose signal in diagnosing and measuring response to treatment in pulmonary TB

Secondary

Measure	Time frame	Description
measuring response to TB treatment over time with the electronic nose	18 months	cohort of patients newly deteted with PTB will be followed with the enose device over time to monitor disease activity, until end of treatment

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026