Assessing and Monitoring the Efficacy of Sulfadoxine/ Pyrimethamine (SP) and the Combination of SP Plus Artesunate for Uncomplicated Malaria Infections Among Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 390
- 试验地点
- 4
- 主要终点
- Clinical and parasitologic failure rate
研究概览
简要总结
This is an ongoing monitoring activity of efficacy of sulfadoxine-pyrimethamine (SP), which is the current national treatment of choice for uncomplicated malaria in Tanzania, and a combination of SP and artesunate among children < 5 years in 3 sites in rural Tanzania.
Protocol was amended in 2004 to (1) include lumefantrine+artemether, the newly identified first-line treatment for malaria to be introduced into Tanzania in 2006; (2) on a limited basis, include adult patients; (3) extend follow-up to 28 days; (4) investigate whether treated bednets would reduce confounding by reinfection
详细描述
This is an ongoing monitoring activity of efficacy of sulfadoxine-pyrimethamine (SP), which is the current national treatment of choice for uncomplicated malaria in Tanzania, and a combination of SP and artesunate among children < 5 years in 3 sites in rural Tanzania.
Protocol was amended in 2004 to (1) include lumefantrine+artemether, the newly identified first-line treatment for malaria to be introduced into Tanzania in 2006; (2) on a limited basis, include adult patients; (3) extend follow-up to 28 days; (4) investigate whether treated bednets would reduce confounding by reinfection
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children < 5 years of age (in one site, patients of all ages are eligible).
- •Documented fever (axillary temperature >= 37.5oC) in the absence of another obvious cause of fever or other serious or chronic medical condition
- •Unmixed infection with P. falciparum of between 2,000 and 250,000 asexual parasites/mm3
- •Patients' or the patients' parent's or guardian's informed consent and willingness to participate in the study
排除标准
- •Any evidence of severe malaria that would require hospitalization for treatment.
- •Reported allergy to any antimalarial drugs, including sulfa and artemisinin drugs.
- •History of pregnancy or delayed menstrual period
- •Breastfeeding a child less than 8 weeks of age
结局指标
主要结局
Clinical and parasitologic failure rate
次要结局
未报告次要终点