NCT00725777已完成不适用
Efficacy and Safety of Artemether Lumefantrine Combination Therapy for the Treatment of Malaria Due to Plasmodium Ovale, Plasmodium Malariae, and Mixed Plasmodium Infections in Gabon
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Parasitological cure rate on day 28
研究概览
简要总结
Patients with non-falciparum infection will be given artemether-lumefantrine for three days and will be followed up for 28 days. Besides efficacy and safety evaluations a substudy on immunology will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients between the age of 6 months and 60 years and with a minimum of 5kg bodyweight
- •Presence of uncomplicated malaria confirmed by: i)fever or history of fever in the previous 4 days, and ii)positive microscopy of P. malariae or P. ovale or mixed infection with P.falciparum with parasite density > 50-200000/μl of blood
- •Written informed consent
排除标准
- •Patients with presence of other clinical conditions requiring hospitalization
- •Presence of other febrile conditions
- •Presence of significant anemia, defined by hemoglobin < 7g/dl
- •Known history of hypersensitivity,allergic or adverse reactions to artemether or lumefantrine
- •Intake of any antimalarial or antibiotics with known antimalarial activity in the preceding 2 weeks
- •Pregnant and breast feeding females
研究组 & 干预措施
A
Experimental
干预措施: artemether-lumefantrine (Drug)
结局指标
主要结局
Parasitological cure rate on day 28
时间窗: D28
次要结局
- Frequency and severity of drug related adverse events(D28)
研究者
Michael Ramharter
Ass. Prof. PD
Albert Schweitzer Hospital
研究点 (1)
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