Clinical Utility of TB-LAM in the Diagnosis of Active TB in Hospitalized HIV-infected Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 主要终点
- Specificity against microbiological reference standard
研究概览
简要总结
Tuberculosis (TB) is still the leading cause of death in HIV-infected patients. Early diagnosis of TB substantially improves the survival of HIV-infected patients. Urine based detection of lipoarabinomannan (LAM) provides promising methods for quick diagnosis of TB in HIV-infected patients. However, the sensitivity and specificity of TB-LAM is still not well established, especially in area where non-tuberculosis mycobacterium is also prevalence. Here we aimed to evaluate the clinical utility of TB-LAM in diagnosis of active TB in hospitalized HIV-infected patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized HIV-infected patients.
- •Willing to participate into the study.
排除标准
- •Already diagnosed with active TB
- •Received any anti-tuberculosis drugs and/or quinolone for more than 7 days.
结局指标
主要结局
Specificity against microbiological reference standard
时间窗: 2 months
1-Number of TB-LAM negative/Number of negative by culture or Gene Xpert or smear
Sensitivity against microbiological reference standard
时间窗: 2 months
Number of TB-LAM positive/Number of positive by culture or Gene Xpert
次要结局
- Sensitivity against composite reference standard(2 months)
- Specificity against composite reference standard(2 months)
研究者
Jun Chen
Shanghai Public Health Clinical Center
Shanghai Public Health Clinical Center