Vanderbilt-Zambia Innovations in Global Health Technologies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 278
- 试验地点
- 1
- 主要终点
- Enhancement of malaria RDT to detect low levels of P falciparum parasites
研究概览
简要总结
Investigators will evaluate approaches using magnetic bead capture, isolation, and surface tension valve transfer of biomarkers to process capillary blood in order to improve the sensitivity of already approved Rapid Diagnostic Tests (RDTs) for detection of human malaria infection. Results will be compared to those obtained using unenhanced capillary blood specimens directly applied to approved malaria RDTs. Participants seeking care for possible malaria in Zambia will be recruited to enroll in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals giving written informed consent for themselves
- •Children under the age of 18 for whom a parent or guardian can give consent
- •Individuals seeking care or treatment of suspected or possible malaria
- •Individuals being screened as a contact of someone with recent malaria
- •Other individuals willing to have their blood tested for malaria
排除标准
- •Anyone over 18 unwilling or unable to provide informed consent
- •Anyone under 18 who does not have a parent or guardian to give consent
- •Anyone between the age of 12 and 18 who does not give assent
结局指标
主要结局
Enhancement of malaria RDT to detect low levels of P falciparum parasites
时间窗: 5 years
The expected outcome of this research project is to enhance the ability of standard malaria RDTs to detect low levels of Plasmodium falciparum malaria in human capillary blood.
次要结局
未报告次要终点