Reagent Evaluation Plan: Tuberculosis Diagnosis by Flow Cytometry (Project Orion)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- DTB assay for rapid detection and drug sensitivity testing of Mtb using sputum specimens
研究概览
简要总结
Tuberculosis and HIV continue to be major public health problems in resource constrained settings like Zambia. Zambia is among the top 30 highest burden countries globally. The major drivers of TB in the Africa region is the HIV epidemic. Inadequate TB diagnostic tools with failure to make a timely diagnosis and start appropriate treatment are the major impediments to TB control in Zambia and globally.
详细描述
Project Orion is focused on utilizing Flow Cytometry Technology to screen and diagnose tuberculosis. There are two assays being tested under this Project:
- Activated TB assay for differentiation of latent and active TB infection using blood samples and
- Direct TB assay (DTA) for rapid detection and DST of Mycobacterium tuberculosis (Mtb) using sputum specimens.)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presumptive TB patients (patients recommended for tuberculosis diagnostic testing and not on ATT)
- •Patients with multi-drug resistant TB (MDR-TB)
- •Paediatric patients (< 15 years old)
- •Patients suspected of extra-pulmonary tuberculosis
- •Patients with TB/HIV co-infection
排除标准
- •Unable/unwilling to sign Informed consent
结局指标
主要结局
DTB assay for rapid detection and drug sensitivity testing of Mtb using sputum specimens
时间窗: The duration of this project is 9 months.
To evaluate the clinical utility of the test reagent(s) compared to diagnostic gold Standard: Culture and Xpert MTB/Rif along with clinical (empiric) diagnosis
ATB assay for differentiation of latent and active TB infection using Blood samples
时间窗: The duration of this project is 9 months.
To evaluate the clinical utility of the test reagent(s) compared to diagnostic gold Standard: Culture and Xpert MTB/Rif along with clinical (empiric) diagnosis
次要结局
未报告次要终点
研究者
Stewart Reid
co-investigator
University of Alabama at Birmingham