Mycobacterium Tuberculosis Infection Diagnosis in Patients Above 75 Years Old/ Performance of Interferon Gamma Releasing Assays (IGRA)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Number of positive, indeterminate, negative tests in each group
研究概览
简要总结
Background: Diagnosis and screening for latent tuberculosis in old patients is of special interest in regards of the morbidity-mortality of this disease in that context.
TB-infection diagnosis based on immunological memory detection can be impaired with age. New blood tests (QFTB-G and T-SPOT.TB) specific for MTB infection have not been evaluated in those old patients.The primary endpoint of this study is the evaluation of the IGRAS for active TB diagnosis in patients above 75 years old.
详细描述
In vitro Interferon Gamma releasing Assay (IGRA) are recommended for LTBI screening as or instead of TST, but there accuracy in those old patients are not known: as immune responses are impaired in elderly and some of them have already met M tuberculosis before active antibiotherapy exists.The aim of this study is to evaluate characteristics of the two commercials tests IGRA T-spot-TB® and Quantiferon-TB-gold- in tube® and TST in old patients with or without active Tuberculosis.
Principal outcome:
- 3 tests performance for active TB diagnosis in patients older than 75 years-old
Secondary outcomes :
- concordance between IGRAs.
- non-concordant results analysis
- concordance of IGRAs results with time of TB-infection
- biobank
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 75 years
- •Consent signed
- •hospitalized patient with start treatment of Tuberculosis disease
- •French social right
排除标准
- •Tuberculosis disease treatment since 7 days
- •No 3 months follow-up possible
- •Immunosuppression
结局指标
主要结局
Number of positive, indeterminate, negative tests in each group
时间窗: month27
次要结局
- Test results in clinical LTBI patients(month 27)
- Blood samples collection in order to test new hypothesis in patients with non-concordant results(month 27)
- Correlation with TB-infection date(month 27)
- Performance comparison between tests (T-SPOT.TB®, Quantiferon-Gold-IT®)(month 27)