C-TST for Diagnosis of Latent Mycobacterium Tuberculosis Infection in Indonesia (C-TST)
31 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
300
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Jakarta Timur (East Jakarta)
-
Jakarta, Jakarta Timur (East Jakarta), Indonesia, 13220
- RSUP Persahabatan (Persahabatan General Hospital)
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Acceptance rate between C-TST and IGRA test in identifying latent TB infection in household and close contact populations.
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Safety endpoints: Incidence of all AEs within 7 days after skin test injection.
Periodo de tiempo: within 7 days after the skin test
|
|
within 7 days after the skin test
|
|
Incremental Cost Effectiveness Ratio
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
26 de mayo de 2025
Finalización primaria (Actual)
21 de agosto de 2025
Finalización del estudio (Actual)
21 de agosto de 2025
Fechas de registro del estudio
Enviado por primera vez
8 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de mayo de 2026
Publicado por primera vez (Actual)
14 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
31 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CTST-INA-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .