Safety and Efficacy of Methylene Blue Combined With Artesunate or Amodiaquine for Malaria Treatment in Children of Burkina Faso: a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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 (definition chapter 11)
研究概览
简要总结
The primary objective of this trial is to study the safety of the combination methylene blue (MB)-artesunate (AS) and MB-amodiaquine (AQ) in treating malaria among children compared to the safety of an AS-AQ regimen. The secondary objective is to investigate the efficacy of MB-AS and MB-AQ.
详细描述
Objectives: The primary objective of this trial is to study the safety of the combination methylene blue (MB)-artesunate (AS) and MB-amodiaquine (AQ) given over three days in 6-10 year old children with uncomplicated falciparum malaria in a malaria endemic area compared to the safety of a three days AS-AQ regimen. Secondary objectives are to investigate the efficacy of MB-AS and MB-AQ.
Population: Children aged 6-10 years with uncomplicated malaria from Nouna town.
Sample size: N= 180 (n=60 for each group).
Treatment: The participants in the MB-AS group will receive orally twice daily 9mg/kg MB combined with once daily 4mg/kg AS over 3 days. The participants in the MB-AQ group will receive orally twice daily 9mg/kg MB combined with once daily 10mg/kg AQ over 3 days. The participants of the comparator group will receive a 3 day regimen of once daily oral AS (4mg/kg) combined with once daily AQ (10mg/kg).
Endpoints: The primary endpoint is the number of adverse events (AE) after drug intake until day 28. Secondary endpoints are the number of serious adverse events (SAE), adequate clinical and parasitological response (ACPR) rate on day 28, clinical and parasitological failure rates on day 3, 7, 14 and 28, changes in haematocrit until day 28, and fever and parasite clearance time.
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 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Complicated or severe malaria
- •Any apparent significant disease
- •Anaemia (haematocrit < 21%)
- •Treated in the same trial before
- •Antimalarial treatment prior to inclusion (last three days), except children having been treated with chloroquine
结局指标
主要结局
Incidence of observed and self-reported non-serious adverse events over the 28 days observation period (definition chapter 11)
次要结局
- Incidence of serious adverse events (definition: chapter 11) over the 28 days observation period
- ACPR rate until D28
- Early treatment failure (ETF) rate
- Late clinical failure (LCF) rate at D14 and D28
- Late parasitological failure (LPF) rate at D14 and D28
- Fever clearance time
- Parasite clearance time
- Change in haematocrit after 2, 3, 7, 14 and 28 days compared to baseline