- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01007396
Diagnosis of Tuberculosis Infection in Health Care Workers Using Ex-vivo Interferon-gamma Assay
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Seoul, Korea, Republikken, 135-710
- Samsung Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- doctors and nurses newly hired at Samsung Medical Center between February, 2008 and November, 2008.
Exclusion Criteria:
- Non-applicable
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: new healthcare workers
doctors and nurses who were newly hired in 2008 at the Samsung Medical Center
|
In only new healthcare workers, the 1-step TST and quantiFERON-TB Gold In-Tube test were performed.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Annual Incidence of Tuberculosis Infection Among Newly Employed Doctors and Nurses in Korea
Tidsramme: QFT-IT test was performed at enrollment and repeated at point of one year after enrollment. So, the length of timw which from the start of the first test of very first participant to the end of second test of very last participant is 2 years.
|
The participants performed QuaniFERON-TB Gold In-Tube test (QFT-IT test).
Annual infection of tuberculosis infection was evaluated with the conversion of QFT-IT test through annual check up of QFT-IT test.
The definitions for QFT-IT test conversion was based on the CDC definition (Baseline IFN-r < 0.35 IU/ml and follow-up IFN-r ≥ 0.35 IU/ml).
|
QFT-IT test was performed at enrollment and repeated at point of one year after enrollment. So, the length of timw which from the start of the first test of very first participant to the end of second test of very last participant is 2 years.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Negative Conversion Rate in Follow-up QuantiFERON-TB Gold In-Tube Test (QFT-IT Test) After Treatment of Latent Tuberculosis Infection (LTBI)
Tidsramme: 3 months after LTBI treatment
|
The percentage of participants with negative conversion in follow-up QFT-IT test after LTBI treatment, out of those who had QFT-IT test conversion after one year of employment and agreed to undergo treatment for LTBI according to our recommendation Participants with QFT-IT test conversion were recommended for LTBI therapy using 3 months of daily isoniazid and rifampicin, which was the regular treatment for LTBI in our institution. The QFT-IT test was repeated after LTBI therapy. Negative conversion was defined as baseline IFN-r ≥ 0.35 and follow-up IFN-r < 0.35 IU/ml. |
3 months after LTBI treatment
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Won-Jung Koh, M.D., Samsung Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart
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 (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2007-09-019
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