A Randomized, Double Blind Trial on the Efficacy and Safety of Amodiaquine-Artesunate and Amodiaquine Alone in the Treatment of Children With Uncomplicated Falciparum Malaria
试验速览
- 阶段
- 4 期
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Parasitological and clinical cure rates by days 14 and 28
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of two antimalarial drug regimes, namely amodiaquine versus amodiaquine-artesunate, in the treatment of children with uncomplicated malaria. Also, genetic host factors which might influence efficacy and/or safety will be examined.
详细描述
Malaria remains a major cause of morbidity and mortality among children in sub-Saharan Africa. Current malaria control largely consists of rapid treatment of patients. Amodiaquine-artesunate and other combinatory treatment regimes including amodiaquine are now being introduced as first-line antimalarial drugs in several African countries. However, data on the efficacy and safety of amodiaquine and amodiaquine-artesunate are scarce. In addition, there is evidence that common genetic host factors, e.g. sickle cell trait, may influence efficacy and safety of these drugs. To examine efficacy and safety of the named drugs as well as a potential influence of genetic host factors on these outcomes a randomized, double blind trial among 400 children with uncomplicated malaria is performed in northern Ghana.
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
- Double
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
- •Male and female outpatients aged 6 to 59 months
- •Body weight >5 kg
- •Uncomplicated Plasmodium falciparum malaria
- •Mono-infection with P. falciparum with an asexual parasite density between 2,000 to 200,000 parasites/μl
- •Axillary temperature ≥37.5°C
- •Ability to tolerate oral therapy
- •Informed consent by the legal representative of the subject
- •Residence in study area
排除标准
- •Previous participation in this clinical trial
- •Haemoglobin <5 mg/dl
- •Mixed plasmodial infection
- •Danger signs (unable to drink; repeated vomiting; recent history of convulsions;lethargic or unconscious state; unable to stand up or to sit) and signs of severe malaria as defined by WHO.
- •Any other severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection)
- •Concomitant disease masking assessment of response
- •History of allergy or intolerance against study medications
结局指标
主要结局
Parasitological and clinical cure rates by days 14 and 28
Parasite and fever clearance times
Carrier rates of sexual parasite stages at days 7, 14 and 28
Incidence rates of adverse events
次要结局
- Incidence rate of haematological and biochemical evidence of drug-induced toxicity
- Primary endpoints in children with and without various genetic host factors