NCT03044509Unknown不适用
Evaluation and Validation of Novel Immunodiagnostic Tests for Childhood Tuberculosis Infection and Disease in Switzerland. The CITRUS (ChIldhood TubeRcUlosis in Switzerland) Study.
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 190
- 试验地点
- 8
- 主要终点
- Improvement of immunodiagnostic tests for TB in children.
研究概览
简要总结
- The primary objective is to improve the sensitivity of novel immunodiagnostic tests for detection of TB disease in children.
- The secondary objective is to determine biomarkers that discriminate children with TB infection and disease.
详细描述
- This will be done by measuring a variety of parameters in the blood samples and compare them with the current diagnostic gold standard for TB or for culture/NAAT non-confirmed TB cases a consensus case definition is used.
Currently available immunodiagnostic tests (IGRA/TST) will be compared to novel immunodiagnostic tests which will include:
- several novel, additional M. tuberculosis-specific Antigens
- cytokines that are highly expressed
- Since there is no diagnostic gold standard for TB infection we will rely on a clinical composite reference standard for diagnosing TB infection. Biomarkers will be determined by:
- including M. tuberculosis-specific antigens that are specifically expressed in either TB infection or disease,
- measuring phenotypes and cytokine production of M. tuberculosis-specific cells.
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
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all children / adolescents < 18 years of age undergoing evaluation for TB exposure, infection or disease.
排除标准
- •children / adolescents with TB infection or disease who have already been started on anti-mycobacterial treatment, children who have been treated for TB previously.
结局指标
主要结局
Improvement of immunodiagnostic tests for TB in children.
时间窗: 27 months
Based on current evidence it is estimated that the sensitivity of the immunodiagnostic tests with regard to the identification of patients with TB infection or disease versus no TB is approximately 80 %. By applying a sample size approximation a minimum sample size of 126 patients with TB infection or disease (with a precision given by a 95 % confidence interval with a width of 20 %) will be needed to statistically show a significant result.
次要结局
- Indicative markers identification for TB infection and disease distinction(27 months)
研究者
Dr. Nicole Ritz, MD/PhD
PI
University Children's Hospital Basel
研究点 (8)
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