A Randomized Controlled Trial to Evaluate the Impact of Using a Point-of-care Urine LAM Strip Test for TB Diagnosis Amongst Hospitalized HIV-infected Patients in Resource-poor Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,618
- 试验地点
- 5
- 主要终点
- All-cause mortality
研究概览
简要总结
The novel urine LAM point-of-care strip test offers potential clinical utility to improve TB diagnosis in HIV co-infected patients. Urine LAM strip test performance improves with increasing illness severity and more advanced immunosuppression, thus offering the greatest potential utility in hospitalised HIV-infected patients with advanced immunosuppression (CD4 cell count less than 200). However, in the context of high rates of empiric treatment and the availability of other novel TB diagnostics, the clinical impact of the urine LAM strip test is unknown. This study will investigate the impact of the urine LAM strip test. The study hypothesis is that the urine LAM strip test, when combined with standard TB diagnostics (smear microscopy and culture) will significantly improve TB treatment-related outcomes (TB-related mortality, morbidity and length of hospital stay) in HIV-infected hospitalized patients when compared to standard TB diagnostics alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-infected (1x rapid HIV test positive)
- •Considered TB suspect by attending doctor (must comprise at least 1 of the following: current fever or cough, drenching night sweats, self-reported LOW)
- •Illness severity sufficient to warrant hospitalization
- •≥18 years old
- •Provision of informed consent
排除标准
- •HIV-uninfected
- •Patients receiving any anti-TB medication in the 60 days prior to testing
- •Unable to provide 30mls urine
- •Inability to provide informed consent
结局指标
主要结局
All-cause mortality
时间窗: 8 weeks
All-cause mortality at 8-weeks after study enrollment
次要结局
- Change in Karnofsky performance index(Baseline and 8 week)
- Hospital length of stay(Date of hospital discharge (max 8 weeks) minus date of admission)
- Diagnostic accuracy of urine LAM strip test(8 weeks)
- Change in TB-related morbidity score(Baseline and 8 weeks)
研究者
Jonathan Peter
Honorary consultant, Department of Medicine
University of Cape Town