Open Randomized Multi-Centre Trial, Comparing Artesunate-Sulfamethoxypyrazine-Pyrimethamine FDC Over 3 Days, Artesunate-Sulfamethoxypyrazine-Pyrimethamine FDC Over 48 Hours and Artemether-Lumefantrine FDC Over 3 Days on P. Falciparum Malaria
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,390
- 试验地点
- 5
- 主要终点
- PCR corrected Adequate Clinical and Parasitological Response
研究概览
简要总结
The purpose of this open randomised multi-centre clinical trial is to test the hypothesis that three pills of the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine, administered over 24 hours is not inferior in efficacy to the same drug administered over 48 hours and that the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine As/SMP fdc, independently of the duration of its dose interval, is not inferior in efficacy to 6 - 24 pills (number of pills administered to respectively children and adults)of the 60 hours treatment of artemether/lumefantrine for the treatment of uncomplicated P. falciparum malaria.
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
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age at least 6 months,
- •weight at least 5 kg,
- •residing in one of the four countries (Mali, Cameroon, Sudan, Rwanda),
- •able to receive oral treatment,
- •having an axillary body temperature of more than 37,5 degrees Celsius or history of fever within the proceeding 24 hours,
- •suffering from a mono specific P. falciparum infection with a parasite density between 2000 and 200000 asexual forms per micro litre of blood.
排除标准
- •presence of severe or complicated malaria (WHO 2000),
- •severe concomitant pathology or one that needs a medical follow-up incompatible with the study,
- •allergic to one of the drugs involved in this study,
- •pregnant (reported pregnancy, detected clinically or with the β HCG test),
- •use of one of the anti-malaria drugs involved in this study during 28 days preceding inclusion.
结局指标
主要结局
PCR corrected Adequate Clinical and Parasitological Response
时间窗: on day 28 (follow-up period)
Early treatment failure
时间窗: between day 0 and day 3
Late clinical failure
时间窗: between day 4 and day 28
Late parasitological failure
时间窗: between day 7 and day 28
次要结局
- Fever clearance(28 day follow-up period)
- Parasitic clearance(28 day follow-up period)
- Parasitological re-infection(28 day follow-up period)
- Gametocyte carriage(28 day follow-up period)
- Safety - Adverse events(28 day follow-up period)
- Haemoglobin levels(28 day follow-up period)
- Clinical and biological tolerance (Haemogram + Lever tests)(28 day follow-up period)