Assessing the Ability of the T-SPOT®.TB Test to Identify Those at Risk of Active Mycobacterium Tuberculosis Infection Using the Normalized TB Specific Lymphocyte Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 676
- 试验地点
- 1
- 主要终点
- T-Spot
研究概览
简要总结
The primary objective of this clinical research study is to demonstrate performance of the normalized TB specific lymphocyte response in identifying patients with active TB disease. The secondary exploratory objective is to demonstrate that active TB cannot be identified using an antigen-to-mitogen ratio derived from an ELISA-based IGRA.
详细描述
The target number of subjects is 100 active TB and 100 active TB excluded . This study will enroll up to 680 subjects (based on previous enrolment rates of approximately 300-350 subjects enrolled for 50 active TB and 50 active TB excluded).
Study Duration: 6 months
All subjects enrolled in this study will be men or women, aged 18 years or older.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cohort 1a and 1b
- •• Must be at least 18 years of age
- •Must be able to provide informed consent
- •Must be able to provide a minimum of 10 mL of whole blood at each visit (16mL for immunocompromised i.e. HIV+)
- •Must be T-SPOT.TB positive
- •First visit suspect TB subjects with no prior history of TB diagnosis Inclusion Criteria: Cohort 2a and 2b
- •Must be at least 18 years of age
- •Must be able to provide informed consent
- •Must be able to provide a minimum of 10 mL of whole blood at each visit (16mL for immunocompromised i.e. HIV+)
- •Must be T-SPOT.TB positive
- •No prior history of TB diagnosis
排除标准
- •Cohort 1a and 1b
- •• Negative in the T-SPOT.TB test
- •Previous or pre-existing confirmed TB diagnosis
- •On anti-TB treatment for more than 1 week*
- •Not meeting inclusion criteria Exclusion Criteria: Cohort 2a and 2b
- •Negative T-SPOT.TB test
- •Previous or pre-existing confirmed TB diagnosis
- •On anti-TB treatment
- •Symptoms of active TB
- •Not meeting inclusion criteria
结局指标
主要结局
T-Spot
时间窗: 6 month study
The primary objective of this clinical research study is to demonstrate performance of the normalized TB specific lymphocyte response (NTBSLR) in identifying patients with active TB disease. The secondary exploratory objective is to demonstrate that active TB cannot be identified using an antigen-to-mitogen ratio derived from an ELISA-based IGRA.
次要结局
未报告次要终点