Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
389 participants
INTERVENTIONAL
2013-11-30
2017-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
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
DIAGNOSTIC
NONE
Study Groups
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Group 1 - 20 PTB patients aged >18yrs
Group 1 - 20 TB patients aged \> 18 yrs 5 min exhaled breath sampling with nose clamp
5 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
Group 2 - 20 TB suspects > 18 yrs
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
5 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
group 3 - 20 lung patients, non-TB
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
5 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
Group 4 - 20 healthy controls
Group 4 - 20 apparently healthy matched controls 5 min exhaled breath sampling with nose clamp
5 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
Group 5 - 7 newly diagnosedMDR PTB pts
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
5 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
group 6 - cohort of TB suspects
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
5 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
Interventions
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5 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* voluntarily participating
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Gadjah Mada University
OTHER
The Enose Company, Zutphen the Netherlands
UNKNOWN
Tjip van der Werf
OTHER
Responsible Party
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Tjip van der Werf
Professor
Locations
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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
Countries
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References
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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.
Other Identifiers
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KE/FK/859/EC
Identifier Type: REGISTRY
Identifier Source: secondary_id
TBDIAGNOSE
Identifier Type: -
Identifier Source: org_study_id
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