NCT00168948Unknown4 期
Intermittent Treatment With Sulfadoxine-Pyrimethamine for Malaria Control in Children: A Randomised, Double Blind, and Placebo-Controlled Clinical Trial
适应症
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 1,200
- 主要终点
- Efficacy and safety of IPTi with SP
研究概览
简要总结
- intermittent preventive treatment with SP in children to evaluate efficacy and safety of this drug combination in children in northern Ghana
详细描述
- Sulfadoxine and pyrimethamine have long been used for malaria prevention and treatment. In this study, following suggestions of WHO, these drugs are used for intermittent treatment.
- It will be tested if this approach reduces the number of malaria attacks and ameliorates the severity of the disease
- It will also be determined if anemia due to malaria, which is prevalent in northern Ghana, may be reduced
- Moreover, the interaction between red cell polymorphisms such as HbS, HbC, alpha-thalassemia and glucose-6-phosphate dehydrogenase deficiency and SP will be examined
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 2 Months 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •informed consent by parents or guardian
- •no concomitant serious disease
- •age >2 months
排除标准
- •serious allergy or hypersensitivity to sulfonamides or pyrimethamine
- •no severe hepatic or renal dysfunction
- •serious breach of study protocol
结局指标
主要结局
Efficacy and safety of IPTi with SP
Impact of IPTi on incidence on malaria attacks
Impact of IPTi on anemia
次要结局
- Interaction between erythrocyte polymorphisms and SP
- Influence on parasite multiplicity
- Impact on child development
研究者
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