Randomized Trial of the Effectiveness of Amodiaquine-Artesunate, Amodiaquine-Sulfadoxine-Pyrimethamine, and Chloroquine-Sulfadoxine-Pyrimethamine, for Treatment of Uncomplicated Malaria in Gambian Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,800
- 试验地点
- 2
- 主要终点
- Clinical failure by day 28
研究概览
简要总结
The purpose of this trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings, without supervision of doses other than the first dose.
详细描述
Children aged 0.5-10 years presenting at health centres with fever or history of fever and other symptoms suggestive of malaria will be screened; children found to have uncomplicated Plasmodium falciparum malaria will be randomized to receive treatment with AS/AQ, SP/AQ or SP/CQ. A drug dispenser will supervise the first dose of medication and subsequent doses will be given to the child's parent to be administered at home, unsupervised by the study team. Patients will be visited at home three days later. Unused medication will be counted and the mother will be asked about the number of doses the child received and any side effects. Children will be seen again 2 and 4 weeks after treatment to collect finger prick samples for packed cell volume (PCV) and malaria microscopy. The primary endpoint is clinical failure by day 28. Analysis will be by intention to treat.
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 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presentation at health centre with febrile illness
- •Monoinfection with P. falciparum
- •Parasitaemia >=500/microlitre
- •Fever or history of fever
排除标准
- •Signs of severe or complicated malaria (persistent vomiting with or without dehydration, history of convulsion during the present illness, inability to sit or stand, parasitaemia >200,000/ul)
- •Severe malnutrition
- •Clinically evident concomitant disease
- •PCV <20%
- •History of allergy to the study medications
- •Residence outside the study area and hence difficult to follow up
结局指标
主要结局
Clinical failure by day 28
Incidence of adverse events
次要结局
- Compliance with treatment regimen
- Parasitological failure by day 28
- Clinical failure by day 14
- Parasitological failure rate by day 14
- Mean PCV on day 28
- Gametocyte carriage rates
- Transmissibility after treatment