ENOSE in Pulmonary Tuberculosis in Yogyakarta

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: 5 min exhaled breath sampling with soft nose clamp


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >18yrs voluntarily participating Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 - 20 PTB patients aged >18yrs<br>Group 1 - 20 TB patients aged > 18 yrs 5 min exhaled breath sampling with nose clamp | Other: 5 min exhaled breath sampling with soft nose clamp<br>* 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<br>* Other names: AEONOSE portable exhaled breath sampling;|
| Experimental: Group 2 - 20 TB suspects > 18 yrs<br>Group 2 - 20 non-TB patients > 18 yrs (screened for TB - but appear to test negative for TB, and diagnosed with other conditions including bronchiectasis, etc) 5 min exhaled breath sampling with nose clamp | Other: 5 min exhaled breath sampling with soft nose clamp<br>* 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<br>* Other names: AEONOSE portable exhaled breath sampling;|
| Experimental: group 3 - 20 lung patients, non-TB<br>Group 3 - 20 patients with a lung disease - no TB suspects (recruited from Lung Clinics in Yogyakarta; lung cancer, COPD, etc) 5 min exhaled breath sampling with nose clamp | Other: 5 min exhaled breath sampling with soft nose clamp<br>* 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<br>* Other names: AEONOSE portable exhaled breath sampling;|
| Experimental: Group 4 - 20 healthy controls<br>Group 4 - 20 apparently healthy matched controls 5 min exhaled breath sampling with nose clamp | Other: 5 min exhaled breath sampling with soft nose clamp<br>* 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<br>* Other names: AEONOSE portable exhaled breath sampling;|
| Experimental: Group 5 - 7 newly diagnosedMDR PTB pts<br>Group 5 - 7 newly diagnosed MDRTB patients enrolled before start of treatment, to be followed 8 months, until after end of treatment 5 min exhaled breath sampling with nose clamp | Other: 5 min exhaled breath sampling with soft nose clamp<br>* 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<br>* Other names: AEONOSE portable exhaled breath sampling;|
| Experimental: group 6 - cohort of TB suspects<br>300 more individuals, suspected to have TB - final diagnosis by standard procedures plus sputum culture plus follow-up for >2 years 5 min exhaled breath sampling with nose clamp | Other: 5 min exhaled breath sampling with soft nose clamp<br>* 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<br>* Other names: AEONOSE portable exhaled breath sampling;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary tuberculosis; electronic nose; diagnostic accuracy