Clinical trial NCT02219945: ENOSE in Pulmonary Tuberculosis in Yogyakarta
Official title: The Accuracy of the eNose in the Diagnostics and Monitoring of Treatment of Treatment-naive TB Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Tuberculosis Suspected
Other Specified Chronic Obstructive Pulmonary Disease
Pulmonary Tuberculosis TB (+) Histology, (-) Bacteriology
Keywords: pulmonary tuberculosis; electronic nose; diagnostic accuracy
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Gadjah Mada University
name: The Enose Company, Zutphen the Netherlands
First posted: 2014-08-19
Enrollment: 389
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* age \>18yrs
* voluntarily participating

Exclusion Criteria:

-

Primary outcomes:
measure: diagnostic precision of electronic nose signal in pulmonary TB
timeFrame: 18 months
Secondary outcomes:
measure: measuring response to TB treatment over time with the electronic nose
timeFrame: 18 months
Other outcomes:
Locations:
city: Yogyakarta
country: Indonesia
facility: patients - at 5 lung clinics (Minggiran, Kalasan, Kotagede, Bantul, Kuonprogo) connected with Sudjarto Teachnig Hospital; healthy controls among students and staff of Hospital and Gadjah Mada Universitas
state: Jalan Kesehatan no.1, Yogyakarta
Study officials:
References:
citation: Saktiawati AMI, Subronto YW, Stienstra Y, Sumardi, Supit F, van der Werf TS. Sensitivity and specificity of routine diagnostic work-up for tuberculosis in lung clinics in Yogyakarta, Indonesia: a cohort study. BMC Public Health. 2019 Apr 2;19(1):363. doi: 10.1186/s12889-019-6658-8.