ENOSE in Pulmonary Tuberculosis in Yogyakarta (YOGYATBNOSE)

Tjip van der Werf

Status: Completed

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

Treatments: Other: 5 min exhaled breath sampling with soft nose clamp

Study type: Interventional

Funder types: Other

Identifiers

NCT02219945

KE/FK/859/EC (Registry Identifier)

TBDIAGNOSE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 389 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age >18yrs
• voluntarily participating

Exclusion criteria

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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389 participants in 6 patient groups

Group 1 - 20 PTB patients aged >18yrs

Experimental group

Description:

Group 1 - 20 TB patients aged \> 18 yrs 5 min exhaled breath sampling with nose clamp

Treatment:

Other: 5 min exhaled breath sampling with soft nose clamp

Group 2 - 20 TB suspects > 18 yrs

Experimental group

Description:

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

Treatment:

Other: 5 min exhaled breath sampling with soft nose clamp

group 3 - 20 lung patients, non-TB

Experimental group

Description:

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

Treatment:

Other: 5 min exhaled breath sampling with soft nose clamp

Group 4 - 20 healthy controls

Experimental group

Description:

Group 4 - 20 apparently healthy matched controls 5 min exhaled breath sampling with nose clamp

Treatment:

Other: 5 min exhaled breath sampling with soft nose clamp

Group 5 - 7 newly diagnosedMDR PTB pts

Experimental group

Description:

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

Treatment:

Other: 5 min exhaled breath sampling with soft nose clamp

group 6 - cohort of TB suspects

Experimental group

Description:

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

Treatment:

Other: 5 min exhaled breath sampling with soft nose clamp