Efficacy and Safety of Artesunate-amodiaquine Combined With Methylene Blue for Falciparum Malaria Treatment in African Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- P. falciparum gametocyte prevalence
研究概览
简要总结
Title: Efficacy and safety of artesunate-amodiaquine combined with methylene blue for falciparum malaria treatment in African children: randomised controlled trial.
Design: Mono-centre, two arms, open randomized controlled study in children with uncomplicated falciparum malaria in Burkina Faso.
Phase: Phase II.
Objectives: The primary objective of this trial is to study the efficacy and safety of the triple therapy artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) given over three days in young children with uncomplicated falciparum malaria in Burkina Faso compared to the local standard three days artemisinin-based combination therapy (ACT) AS-AQ regimen.
Population: Children aged 6-59 months with uncomplicated falciparum malaria from Nouna Hospital in north-western Burkina Faso.
Sample size: 180 patients (90 per study arm).
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
- •6-59 months old children (male and female)
- •Weight ≥ 6kg
- •Uncomplicated malaria caused by P. falciparum
- •Asexual parasites ≥ 2 000/µl and ≤ 200 000/µl
- •Axillary temperature ≥ 37.5°C or a history of fever during last 24 hours
- •Burkinabe nationality
- •Permanent residence in the study area with no intention of leaving during the surveillance period
- •Informed consent
排除标准
- •Severe malaria (WHO 2000)
- •Vomiting (3 or more within 24 hours before the visit)
- •Any apparent significant disease, including severe malnutrition
- •A history of a previous, significant adverse reaction to either of the study drugs
- •Anaemia (haemoglobin < 7 g/dl)
- •Treated in the same trial before
- •All modern antimalarial treatment prior to inclusion (last seven days)
- •Simultaneous participation in another investigational study
- •Treatment with other investigational drugs
研究组 & 干预措施
artesunate, amodiaquine methylene blue
two arms, open randomized controlled study in children with uncomplicated falciparum malaria in Burkina Faso. Intervention: artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) control: artesunate (AS) - amodiaquine (AQ)
干预措施: artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) (Drug)
结局指标
主要结局
P. falciparum gametocyte prevalence
时间窗: day 14 of follow-up
P. falciparum gametocyte prevalence on day 14 of follow-up (PCR determination)
次要结局
- P. falciparum gametocyte prevalence and density(day 1, 2, 3, 7, and 28 of follow-up)