C-TST for Diagnosis of Latent Mycobacterium Tuberculosis Infection in Indonesia (C-TST)
31. mai 2026 oppdatert av: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Operational Research of Recombinant Mycobacterium Tuberculosis Fusion Protein Tuberculin Skin Test (C-TST) for Diagnosis of Latent Mycobacterium Tuberculosis Infection in Populations Aged 18 Years to 65 Years Old in Indonesia
This is an operational research in household/close contacts of confirmed TB patients to evaluate the effectiveness of C-TST compared to IGRA test in identifying latent TB cases using parameters of effectiveness and safety.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
The study is designed as an operational research.
After informed consent and screening by evaluation of medical history followed by thorough physical examination and vital signs test (body temperature, blood pressure, pulse rate, and respiration rate) and urine pregnancy test for women of childbearing potential, blood collection will be done in 300 eligible subjects for IGRA test, followed by C-TST skin test.
Measure the body temperature of all subjects 30 min after the skin test.
Test results will be observed with skin reaction at the injection site 48~72 h after the skin test.
Test results along with presence of adverse events until 7 days follow-up will be recorded.
If there are discrepancies in the test result, a T-SPOT test will be conducted after the skin test.
Studietype
Intervensjonell
Registrering (Faktiske)
300
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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Jakarta Timur (East Jakarta)
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Jakarta, Jakarta Timur (East Jakarta), Indonesia, 13220
- RSUP Persahabatan (Persahabatan General Hospital)
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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
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Age 18 years - 65 years old
- Being a close contact or household contact of a TB patient
- Subject and/or legally acceptable representatives of the subject are willing to participate in the research by providing informed consent.
- On the day of enrollment, the axillary body temperature was normal (<37.3 °C)
Exclusion Criteria:
- Pregnant or lactating women
- Individuals with active TB or those presenting symptoms suggestive of TB.
- Patients with acute infectious diseases (such as measles, whooping cough, influenza, pneumonia, etc), acute conjunctivitis, acute otitis media, extensive skin diseases, and allergic constitution.
- Have a history of TB disease
- Received a TST within the last 6 months
- Presence of skin conditions that might interfere with the interpretation after C-TST administration, such as tattoo and abnormal skin condition.
- Currently participating in a clinical trial for medication.
- Condition where researchers believe that there are any situations that may affect the evaluation of the trial.
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: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Diagnostic Testing Arm
The study was a prospective, open-label, non-randomized study.
All subjects underwent IGRA testing (QFT), followed by C-TST administration.
T-SPOT.TB tests were performed only in cases of any discrepancies in the results between C-TST and QFT and were used as part of a composite reference standard.
Subjects then underwent blood collection (6 mL venous blood) using lithium-heparin tube for IGRA Quantiferon® testing, followed by administration of 0.1 mL 5 U C-TST intradermally on the palm side of the forearm using Mantoux method on Day 1. Blood collection and administration of C-TST were performed by an authorized site nurse from each site.
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The study was a prospective, open-label, non-randomized study.
All subjects underwent IGRA testing (QFT), followed by C-TST administration.
T-SPOT.TB tests were performed only in cases of any discrepancies in the results between C-TST and QFT and were used as part of a composite reference standard.
Subjects then underwent blood collection (6 mL venous blood) using lithium-heparin tube for IGRA Quantiferon® testing, followed by administration of 0.1 mL 5 U C-TST intradermally on the palm side of the forearm using Mantoux method on Day 1. Blood collection and administration of C-TST were performed by an authorized site nurse from each site.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Acceptance rate between C-TST and IGRA test in identifying latent TB infection in household and close contact populations.
Tidsramme: 7 days after the skin test
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The primary outcome is the concordance between C-TST and QuantiFERON-TB (QFT) results.
All subjects underwent QFT testing followed by 0.1 mL 5 U C-TST administered intradermally on the forearm using the Mantoux method.
In cases of discrepant results between C-TST and QFT, T-SPOT.TB testing was performed as part of a composite reference standard.
Concordance will be calculated based on agreement rates between the tests.
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7 days after the skin test
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Safety endpoints: Incidence of all AEs within 7 days after skin test injection.
Tidsramme: within 7 days after the skin test
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within 7 days after the skin test
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Incremental Cost Effectiveness Ratio
Tidsramme: Day 7 after skin test
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On the third visit, subjects will be asked to fill out an acceptability questionnaire.
In additional to assess cost-effectiveness, investigator will use primary data obtained from health workers (doctors, nurses, and laboratory workers) as well as cost summary used in laboratories.
Other data will be obtained from secondary data and model assumptions.
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Day 7 after skin test
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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)
26. mai 2025
Primær fullføring (Faktiske)
21. august 2025
Studiet fullført (Faktiske)
21. august 2025
Datoer for studieregistrering
Først innsendt
8. mai 2026
Først innsendt som oppfylte QC-kriteriene
8. mai 2026
Først lagt ut (Faktiske)
14. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CTST-INA-001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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