Identification of Biomarkers for Central Nervous System Tuberculosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 216
- 试验地点
- 3
- 主要终点
- •Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of biomarkers for differentiating CNS Tb and clinically relevant differential diagnosis (sarcoidosis, lymphoma, other infectious cause)
研究概览
简要总结
Rationale:
Tuberculosis(Tb) is still the leading cause of death from infectious disease. Althoughcases have declined over the last decades, the emergence of multi drugresistant strains is causing an increasing problem.
Aims/Hypothesis:
Aimis to identify biomarkers of Central Nervous System Tuberculosis in both CSFand Serum to diagnose.
Methods& Design:
Itis a Prospective, multicenter trial including 3 centers. Patient≥ 18 years of age and clinically suspected Tb will be included for a period of1 year. 108 patients with confirmed and 108 with suspected but ruled out Tb ofCNS will be included. Blood will becollected at Visit 1 and after 6 month at Visit 2. Cerebrospinal fluid willonly be collected at Visit 1. Clinically data will be collected in all patientsincluding CSF examination and MRI. Sample size collection will be performed bythe independent with test. Statistical Package for the Social Sciences (SPSS)will be used for statistical analysis. Primary endpoints include diagnostic accuracy of biomarkers fordifferentially CNS Tb and at 6 months follow up for treatment success andclinical outcome.
Summary:
Establishinga single biomarker or a combination of biomarkers to distinguish CNS Tb fromits most important differential diagnoses would significantly simplify bothdiagnostics and treatment.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically suspected Central Nervous System Tuberculosis.
排除标准
- •â€¢Informed consent not given •Lumbar puncture not possible/not performed before start of treatment.
结局指标
主要结局
•Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of biomarkers for differentiating CNS Tb and clinically relevant differential diagnosis (sarcoidosis, lymphoma, other infectious cause)
时间窗: Baseline ( Date of Patient Enrollment ) and follow-up at 6 months
次要结局
- •Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of biomarkers at 6 month follow up for treatment success and clinical outcome(Baseline ( Date of Patient Enrollment ) and follow-up at 6 months)