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- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Jalan Kesehatan no.1, Yogyakarta
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Yogyakarta, Jalan Kesehatan no.1, Yogyakarta, Indonesië, 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
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- age >18yrs
- voluntarily participating
Exclusion Criteria:
-
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Group 1 - 20 PTB patients aged >18yrs
Group 1 - 20 TB patients aged > 18 yrs 5 min exhaled breath sampling with nose clamp
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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
Andere namen:
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Experimenteel: 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
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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
Andere namen:
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Experimenteel: 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
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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
Andere namen:
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Experimenteel: Group 4 - 20 healthy controls
Group 4 - 20 apparently healthy matched controls 5 min exhaled breath sampling with nose clamp
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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
Andere namen:
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Experimenteel: 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
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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
Andere namen:
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Experimenteel: 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
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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
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
diagnostic precision of electronic nose signal in pulmonary TB
Tijdsspanne: 18 months
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sensitivity and specificity of electronic nose signal in diagnosing and measuring response to treatment in pulmonary TB
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18 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
measuring response to TB treatment over time with the electronic nose
Tijdsspanne: 18 months
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cohort of patients newly deteted with PTB will be followed with the enose device over time to monitor disease activity, until end of treatment
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18 months
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- TBDIAGNOSE
- KE/FK/859/EC (Register-ID: KE/FK/859/EC)
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