- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02219945
ENOSE in Pulmonary Tuberculosis in Yogyakarta (YOGYATBNOSE)
The Accuracy of the eNose in the Diagnostics and Monitoring of Treatment of Treatment-naive TB Patients
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
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Jalan Kesehatan no.1, Yogyakarta
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Yogyakarta, Jalan Kesehatan no.1, Yogyakarta, Indonesien, 55281
- 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
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- age >18yrs
- voluntarily participating
Exclusion Criteria:
-
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Group 1 - 20 PTB patients aged >18yrs
Group 1 - 20 TB patients aged > 18 yrs 5 min exhaled breath sampling with 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
Andre navne:
|
Eksperimentel: 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
|
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
Andre navne:
|
Eksperimentel: 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
|
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
Andre navne:
|
Eksperimentel: Group 4 - 20 healthy controls
Group 4 - 20 apparently healthy matched controls 5 min exhaled breath sampling with 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
Andre navne:
|
Eksperimentel: 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
|
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
Andre navne:
|
Eksperimentel: 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
|
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
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
diagnostic precision of electronic nose signal in pulmonary TB
Tidsramme: 18 months
|
sensitivity and specificity of electronic nose signal in diagnosing and measuring response to treatment in pulmonary TB
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18 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
measuring response to TB treatment over time with the electronic nose
Tidsramme: 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
|
18 months
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Infektioner
- Luftvejsinfektioner
- Luftvejssygdomme
- Lungesygdomme
- Bakterielle infektioner
- Bakterielle infektioner og mykoser
- Gram-positive bakterielle infektioner
- Actinomycetales infektioner
- Mycobacterium infektioner
- Lungesygdomme, obstruktiv
- Lungesygdom, kronisk obstruktiv
- Tuberkulose
- Tuberkulose, lunge
Andre undersøgelses-id-numre
- TBDIAGNOSE
- KE/FK/859/EC (Registry Identifier: KE/FK/859/EC)
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