NCT00304980终止不适用
Comparative Evaluation of the Safety and the Efficacy of Artemether + Lumefantrine (Coartem™) vs. Sulfadoxine + Pyrimethamine (SP) in Both HIV+ and HIV- Adults With Uncomplicated P. Falciparum Malaria in Zambia
Institute of Tropical Medicine, Belgium1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2003年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- PCR corrected clinical and parasitological outcome at day 45
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of sulfadoxine-pyrimethamine (SP) versus artemether-lumefantrine (Coartem) when administered to HIV+ and HIV- patients with uncomplicated P. falciparum malaria. Patients will be randomised to one of the 2 treatment and followed up (until day 14 actively) for 45 days.
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
- 15 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man and non-pregnant women aged between 15 and
- •P.falciparum mono-infection of at least 1,000 parasites/µl.
- •Body temperature ≥ 37.5°C at the moment of enrolment or history of fever in the preceding 48 hrs.
- •Consent from patient obtained.
排除标准
- •Pregnancy.
- •Severe P. falciparum malaria .
- •Documented intake of SP or Coartem two weeks or less prior recruitment.
- •Other cause(s) of fever.
- •Evidence of underlying chronic diseases (cardiac, renal, hepatic, malnutrition).
- •History of allergy to study drug, or known allergy to other Sulphur drugs such as co-trimoxazol.
结局指标
主要结局
PCR corrected clinical and parasitological outcome at day 45
次要结局
- Tolerability
- Clinical recovery
研究者
研究点 (1)
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