ENOSE in Pulmonary Tuberculosis in Yogyakarta

Not Applicable

Completed

• Conditions: Pulmonary Tuberculosis Suspected; Pulmonary Tuberculosis TB (+) Histology, (-) Bacteriology; Other Specified Chronic Obstructive Pulmonary Disease
• Interventions: Other: 5 min exhaled breath sampling with soft nose clamp

• Registration Number: NCT02219945
• Lead Sponsor: Tjip van der Werf

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-08-01
• Study First Submitted QC: 2014-08-15
• Study First Posted: 2014-08-19
• Primary Completion: 2014-12
• Study Completion: 2017-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-31
• Last Update Posted: 2017-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 389

Inclusion Criteria

• age >18yrs
• voluntarily participating

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 4 - 20 healthy controls	5 min exhaled breath sampling with soft nose clamp	Group 4 - 20 apparently healthy matched controls 5 min exhaled breath sampling with nose clamp
Group 1 - 20 PTB patients aged >18yrs	5 min exhaled breath sampling with soft nose clamp	Group 1 - 20 TB patients aged \> 18 yrs 5 min exhaled breath sampling with nose clamp
Group 2 - 20 TB suspects > 18 yrs	5 min exhaled breath sampling with soft nose clamp	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
Group 5 - 7 newly diagnosedMDR PTB pts	5 min exhaled breath sampling with soft nose clamp	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
group 3 - 20 lung patients, non-TB	5 min exhaled breath sampling with soft nose clamp	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
group 6 - cohort of TB suspects	5 min exhaled breath sampling with soft nose clamp	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

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; 🇮🇩 Yogyakarta, Jalan Kesehatan no.1, Yogyakarta, Indonesia