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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.