CTRI/2019/11/021932尚未招募不适用
"Pilot and Validation studies of a new malaria and sickle cell diagnostic device."
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Primary endpoint of the study is the accuracy of the Hemex Malaria device
研究概览
简要总结
The purpose of this Study is to compare the performance of a new malaria diagnostic device(Gazelle) with the current malaria diagnostic technologies such as RDT (Rapid Diagnostic Test),microscopy and PCR (Polymerase Chain Reaction). The study rationale is that Hemex Malariadevice (Gazelle) is faster, easier and comparable to (as good as) microscopy and/or has betteraccuracy for malaria parasites than RDTs, regardless of the species. The study enrollsapproximately 200 patients who presents with fever to the clinic and each patient sample will betested with Gazelle and RDT, and then compare with microscopy and PCR.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 5.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Present with uncomplicated malaria (fever),Other symptomatic patients (fever, chills etc.) visiting the clinic/lab for various diagnostic purposes, Informed consent for all fresh or frozen samples will be obtained from the patient or obtained from the parent/guardian in case the patient is a minor.
排除标准
- •Presence of any serious or chronic illness requiring medical attention Informed consent not provided Malaria diagnosis within the last two months Treatment for malaria in last two months.
结局指标
主要结局
Primary endpoint of the study is the accuracy of the Hemex Malaria device
时间窗: 4 weeks
次要结局
- N/A(N/A)
研究者
研究点 (1)
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