Efficacy of Plasmodium Falciparum Specific Rapid Diagnostic Tests for Assessment of Initial Clearance and Detection of Recurrent Infections After Antimalarial Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Detection of recurrent infection with HRP2 and LDH-based Rapid diagnostic tests during follow up
研究概览
简要总结
The aim of the study was to follow clearance of malaria infections and detection of new malaria episodes after initiation of antimalarial treatment in Tanzanian children. For this purpose the investigators used five diagnostic tools, 2 Rapid Diagnostic tests based on Histidine Rich Protein 2(HRP2) and Lactate dehydrogenase(LDH), 2 microscopical methods and one polymerase chain reaction (PCR). The investigators followed the 53 enrolled children during 42 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children between 6-59 months
- •fever (≤37.5 C) or history of fever during the preceding 24 hours
- •confirmed P.falciparum monoinfection
- •uncomplicated malaria
- •parasite density between 2000-250.000/µL
- •willing/able to comply with the 42 day follow up
- •informed concent from patient/guardian
排除标准
- •children with history of antimalaria drug intake within the last two weeks
- •symptoms / signs of severe disease
结局指标
主要结局
Detection of recurrent infection with HRP2 and LDH-based Rapid diagnostic tests during follow up
时间窗: 2009 June to 2012 May (up to day 42)
Ability to detect recurrent malaria infection with the HRP2 and LDH-Rapid diagnostic tests during the 42 days of follow up was studied through comparing them with three other diagnostic tests.
Clearance time with five diagnostic tests
时间窗: 2009 June to 2012 May (up to day 42)
Children were followed up on 9 occasions until day 42. Mean and median time until clearance after initiation of arthemeter-lumefantrine treatment was measured for HRP2 based Rapid diagnostic tests, LDH-based Rapid diagnostic tests, Giemsa and Acridine Orange stained microscopy and real-time PCR.
次要结局
- Efficiency of P.falciparum specific rapid diagnostic tests(2009 June to 2012 May (up to day 42))
研究者
Anders Björkman
Professor
Karolinska University Hospital