ENOSE in Pulmonary Tuberculosis in Yogyakarta (YOGYATBNOSE)
31. mai 2017 oppdatert av: Tjip van der Werf
The Accuracy of the eNose in the Diagnostics and Monitoring of Treatment of Treatment-naive TB Patients
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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
389
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Jalan Kesehatan no.1, Yogyakarta
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Yogyakarta, Jalan Kesehatan no.1, Yogyakarta, Indonesia, 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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- age >18yrs
- voluntarily participating
Exclusion Criteria:
-
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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
Andre navn:
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Eksperimentell: 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 navn:
|
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Eksperimentell: 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
Andre navn:
|
|
Eksperimentell: 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 navn:
|
|
Eksperimentell: 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
Andre navn:
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Eksperimentell: 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 navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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diagnostic precision of electronic nose signal in pulmonary TB
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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measuring response to TB treatment over time with the electronic nose
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. november 2013
Primær fullføring (Faktiske)
1. desember 2014
Studiet fullført (Faktiske)
1. april 2017
Datoer for studieregistrering
Først innsendt
1. august 2014
Først innsendt som oppfylte QC-kriteriene
15. august 2014
Først lagt ut (Anslag)
19. august 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. juni 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. mai 2017
Sist bekreftet
1. mai 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Infeksjoner
- Luftveisinfeksjoner
- Sykdommer i luftveiene
- Lungesykdommer
- Bakterielle infeksjoner
- Bakterielle infeksjoner og mykoser
- Gram-positive bakterielle infeksjoner
- Actinomycetales infeksjoner
- Mycobacterium infeksjoner
- Lungesykdommer, obstruktiv
- Lungesykdom, kronisk obstruktiv
- Tuberkulose
- Tuberkulose, lunge
Andre studie-ID-numre
- TBDIAGNOSE
- KE/FK/859/EC (Registeridentifikator: KE/FK/859/EC)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .