C-TST for Diagnosis of Latent Mycobacterium Tuberculosis Infection in Indonesia (C-TST)
31 maj 2026 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
300
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Jakarta Timur (East Jakarta)
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Jakarta, Jakarta Timur (East Jakarta), Indonesien, 13220
- RSUP Persahabatan (Persahabatan General Hospital)
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Acceptance rate between C-TST and IGRA test in identifying latent TB infection in household and close contact populations.
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Safety endpoints: Incidence of all AEs within 7 days after skin test injection.
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
26 maj 2025
Primärt slutförande (Faktisk)
21 augusti 2025
Avslutad studie (Faktisk)
21 augusti 2025
Studieregistreringsdatum
Först inskickad
8 maj 2026
Först inskickad som uppfyllde QC-kriterierna
8 maj 2026
Första postat (Faktisk)
14 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
31 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CTST-INA-001
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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