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C-TST for Diagnosis of Latent Mycobacterium Tuberculosis Infection in Indonesia (C-TST)

13. maj 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

300

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Indonesien
    • Jakarta Timur (East Jakarta)
      • Jakarta, Jakarta Timur (East Jakarta), Indonesien, 13220
        • RSUP Persahabatan (Persahabatan General Hospital)

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. Age 18 years - 65 years old
  2. Being a close contact or household contact of a TB patient
  3. Subject and/or legally acceptable representatives of the subject are willing to participate in the research by providing informed consent.
  4. On the day of enrollment, the axillary body temperature was normal (<37.3 °C)

Exclusion Criteria:

  1. Pregnant or lactating women
  2. Individuals with active TB or those presenting symptoms suggestive of TB.
  3. Patients with acute infectious diseases (such as measles, whooping cough, influenza, pneumonia, etc), acute conjunctivitis, acute otitis media, extensive skin diseases, and allergic constitution.
  4. Have a history of TB disease
  5. Received a TST within the last 6 months
  6. Presence of skin conditions that might interfere with the interpretation after C-TST administration, such as tattoo and abnormal skin condition.
  7. Currently participating in a clinical trial for medication.
  8. Condition where researchers believe that there are any situations that may affect the evaluation of the trial.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Recombinant Mycobacterium Tuberculosis Fusion Protein Tuberculin Skin Test (C-TST)
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
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.
7 days after the skin test

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety endpoints: Incidence of all AEs within 7 days after skin test injection.
Tidsramme: within 7 days after the skin test
  1. Overall incidence of AEs;
  2. Immediate AEs within 30 minutes after skin test injection;
  3. Incidence of AEs related to the investigational product;
  4. Incidence of AEs ≥ grade 3;
  5. Incidence of AEs ≥ grade 3 related to the investigational product;
  6. Incidence of AEs leading to withdrawal;
  7. Incidence of AEs related to the investigational product leading to withdrawal; Incidence of all serious adverse events (SAEs) and incidence of SAEs related to the investigational product within 7 days after the skin test.
within 7 days after the skin test
Incremental Cost Effectiveness Ratio
Tidsramme: Day 7 after skin test
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.
Day 7 after skin test

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

Samarbejdspartnere

Indonesian Respiratory Research and Training Foundation

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. maj 2025

Primær færdiggørelse (Faktiske)

21. august 2025

Studieafslutning (Faktiske)

21. august 2025

Datoer for studieregistrering

Først indsendt

8. maj 2026

Først indsendt, der opfyldte QC-kriterier

8. maj 2026

Først opslået (Faktiske)

14. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CTST-INA-001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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