NCT00545935已完成2 期
Safety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso: RCT in the Frame of the A8 Project of SFB 544
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Incidence of observed and self-reported non-serious adverse events over the 28 days observation period
研究概览
简要总结
The purpose of the study is to investigate the safety and efficacy profile of a new paediatric MB formulation combined with AQ or AS and compared to AS-AQ in young African children with uncomplicated 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 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •0.5-5 year (6-59 months) old children
- •uncomplicated malaria caused by P. falciparum
- •asexual parasites ≥ 2000/µ and ≤ 200000/µ
- •axillary temperature ≥ 37.5 Celsius or a history of fever during last 24 hours
- •Burkinabe nationality
- •informed consent
排除标准
- •complicated or severe malaria
- •any apparent significant disease
- •anaemia (haematocrit < 21%)
- •treated in the same trial before
- •modern antimalarial treatment prior to inclusion (last three days), except children having been treated with chloroquine
研究组 & 干预措施
1-Methylenblue-Amodiaquine
Active Comparator
干预措施: Methylenblue-Amodiaquine (MB-AQ) (Drug)
2-Methylenblue-Artesunate
Active Comparator
干预措施: Methylenblue-Artesunate (MB-AS) (Drug)
3-Artesunate-Amodiaquine
Active Comparator
干预措施: Artesunate-Amodiaquine (AS-AQ) (Drug)
结局指标
主要结局
Incidence of observed and self-reported non-serious adverse events over the 28 days observation period
时间窗: 28 days
次要结局
- Fever clearance time(28 days)
- Parasite clearance time(28 days)
- Early treatment failure (ETF) rate(28 days)
- Incidence of serious adverse events (SAE) and the adequate clinical and parasitological response rate (ACPR)(28 days)
- Late clinical failure (LCF) rate at D14 and D28(28 days)
- Late parasitological failure (LPF) rate at D14 and D28(28 days)
- Change in haematocrit after 2,14 and 28 days compared to baseline(28 days)
- MB whole blood concentrations on D3,5 or 7 compared to concentrations after the first dose(28 days)
研究者
研究点 (1)
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