Expanding Xpert Ultra Testing for TB Diagnosis Among HIV-positive Patients Admitted to Hospital in Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,172
- 试验地点
- 8
- 主要终点
- proportion of participants diagnosed with microbiologically confirmed TB and started on TB treatment within 72 hours of enrolment
研究概览
简要总结
The overall aim of this study is to assess the potential of an expanded TB testing strategy to increase the number of HIV-positive patients with microbiologically diagnosed TB who are started on treatment in adult wards of sub-Saharan Africa.
详细描述
To investigate the effect of an expanded TB screening strategy among HIV-positive patients admitted to hospital (including Ultra on sputum, stool and urine, and AlereLAM on urine, performed regardless of presence of TB symptoms) on the proportion of microbiologically-confirmed TB cases starting treatment within 72 hours of enrolment, compared to Ultra testing (on sputum/any tissue) and AlereLAM (on urine) in only those patients who are symptomatic for TB or fulfilling WHO testing recommendations.
to assess the impact of this screening strategy on 2-month all-cause mortality.
• to assess the feasibility of multiple specimens' collection for TB diagnosis within 72 hours of enrolment.
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
- •Adults (18 years old and above)
- •Confirmed HIV infection by serology (including both antiretroviral (ART)- naïve and experienced)
- •Admitted to the hospital (adult medical wards) at the time of enrolment.
排除标准
- •Unable to provide informed consent (if no authorized relatives are in the position to provide the consent)
- •Living outside the catchment area of the participating hospital(s)
- •with plans to migrate outside the catchment area within 2 months after recruitment.
- •Currently receiving anti-TB therapy or having received anti TB therapy in the last 6 months prior to enrolment
- •Receiving preventive TB treatment in the preceding 6 months
- •Patients admitted for traumatic reasons, acute abdomen, delivery (maternal conditions), or for planned/scheduled surgery.
- •Referred from other hospital.
结局指标
主要结局
proportion of participants diagnosed with microbiologically confirmed TB and started on TB treatment within 72 hours of enrolment
时间窗: 72 hours after enrolment
The proportion of participants diagnosed with microbiologically confirmed TB and started on TB treatment within 72 hours of enrolment, separately for intervention and control arm. The numerator is the number of participants per study arm who are diagnosed with microbiologically confirmed TB and start on treatment within 72 hours of enrolment. The denominator is the number of participants enrolled per study arm. We will compare this indicator between both study arms.
次要结局
- The proportion of participants who are diagnosed with TB (irrespective of bacteriological confirmation) and started TB treatment within 72 hours of enrolment.(72 hours after enrolment)
- Eight-week all-cause mortality(8 weeks after enrolment)