Evaluation of a CD4/CD8+ Interferon Gamma Release Assay for Monitoring Anti-Tuberculosis Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Evaluation of a CD4/CD8+ Interferon Gamma Release Assay for monitoring anti-Tuberculosis treatment
研究概览
简要总结
Evaluate the possibility of using an IGRA (Interferon-γ Release Assay) test for monitoring the response to anti-tuberculosis therapy by studying the correlation between the variation in the Interferon-gamma (IFN-γ) response to the QFT-Plus test in the two tubes containing antigens and the gold standard for monitoring TB therapy (culture conversion) in patients with slide positive/culture positive and slide negative/culture positive PTB.
Evaluate the level of agreement between the results of the new QFT Access test and the results of the QFT plus and culture in patients diagnosed with active tuberculosis. To evaluate the level of agreement between QFT Access test results and QFT Plus results in healthy controls and contacts.
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
- 是
入选标准
- •Clinical symptoms consistent with a high probability of having PULMONARY TB disease (probable case), such that they are receiving or are likely to receive ther-apy for active PTB (therapy must not have been initiated for more than 72 hours before recruitment into the study).
- •Positive sputum smear for AAR
- •Positive culture for mycobacterium tuberculosis (confirmed PTB case).
- •Positive nucleic acid amplification (NAA) test for mycobacterium tuberculosis.
排除标准
- •Taken therapy for active tuberculosis or latent TB infection for more than 72 hours.
- •Culture confirmation of M. tuberculosis not obtained.
- •Age less than 18 years.
- •Immunosuppression: HIV-infection, solid organ transplantation, stem cell transplantation, rheumatoid arthritis.
结局指标
主要结局
Evaluation of a CD4/CD8+ Interferon Gamma Release Assay for monitoring anti-Tuberculosis treatment
时间窗: 1. At time of diagnosis (t0) 2. 30+ 4 days after anti-TB treatment initiation (t1) 3. 2 months after anti-TB treatment initiation (t2) 4. At the end of the anti-TB therapy (6 to 9 months) (t3)
Define the degree of correlation between changes in IFN-γ response in the first antigen tube (TB1) and the newly added antigen tube (TB2) and the reference stand-ard of treatment response (culture conversion) in smear-positive and smear-negative/culture-positive pulmonary TB cases
次要结局
未报告次要终点
研究者
Paola Mantegani
Research manager
Ospedale San Raffaele