Randomized Trial of Sulfadoxine-Pyrimethamine Plus Artesunate (SP+AS) Versus SP+AS Plus Primaquine for Clearance of Low Density P. Falciparum Infection in Eastern Sudan
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- P.falciparum parasitaemia detected by PCR on days 3,7 and 14.
研究概览
简要总结
In areas of seasonal malaria transmission, treatment of carriers of malaria parasites, whose parasitaemia persists at very low levels throughout the dry season, could be a useful strategy for malaria control in areas with a short transmission season. We did a randomized trial to compare two regimens for clearance of low level parasitaemia in the dry season.
详细描述
104 individuals with low density Plasmodium falciparum infection detected by polymerase chain reaction (PCR) were randomized to receive sulfadoxine-pyrimethamine and three daily doses of artesunate (SP+AS) or SP+AS and a dose of primaquine (SP+AS+PQ), and were followed up for 14 days during the transmission-free season in Eastern Sudan. Subjects were visited on days 3, 7 and 14 after the start of treatment to record any adverse events and to detect P.falciparum using PCR. PCR positive samples were tested for gametocytes using RT-PCR. Packed cell volume was measured on days 7 and 14.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •infection with P.falciparum detected by PCR
排除标准
- •pregnancy
- •severe anaemia
- •fever or other signs of illness
- •history of allergy to sulfa drugs
- •presence of other species of Plasmodium detected by microscopy
研究组 & 干预措施
1
Sulfadoxine pyrimethamine plus three daily doses of artesunate
干预措施: sulfadoxine-pyrimethamine (SP) plus artesunate (AS) (Drug)
2
Sulfadoxine pyrimethamine plus artesunate plus primaquine
干预措施: primaquine (PQ) plus SP+AS (Drug)
结局指标
主要结局
P.falciparum parasitaemia detected by PCR on days 3,7 and 14.
时间窗: 14 days from start of treatment
次要结局
- Presence of gametocytes detected by RT-PCR on days 3, 7 and 14.(14 days from start of treatment)
- Packed Cell volume on days 7 and 14.(Over 14 days from start of treatment)