NCT00510159已完成2 期
Randomized Double Blind Clinical Trial in Mali, Comparing the Effectiveness of Artesunate + Sulfamethoxypyrazine/Pyrimethamine Versus Praziquantel in the Treatment of S. Haematobium in Children
Dafra Pharma1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2007年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Compare the parasite load between the two treatment arms
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of praziquantel versus As+SMP (Co-Arinate FDC ®) in the treatment of Schistosoma haematobium in 6-15 year old Malian children. The nul-hypothesis in this study is that the combination of As+SMP is more effective than praziquantel in the treatment of S. haematobium infected children.
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 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 6-15 years
- •In good health, according to study doctor
- •Suffering from urinary schistosomiasis, as diagnosed by the presence of S. haematobium eggs in the urine.
- •Residents of Djalakorodji
- •Capable of taking oral medication
- •Written informed consent to participate in the study, obtained from parent or legal guardian.
排除标准
- •Weighing more than 50 kg
- •Being pregnant or lactating at the time of the study
- •Patient has a severe concomitant disease, as determined by the clinical examination, such as cerebral cysticercosis, HIV,...
- •Signs of severe malnutrition (children weighing/measuring more than 3 standard deviations or less than 70% of the median standard reference values determined by WHO, or with systemic oedema affecting both feet).
- •Hypersensitivity to As, SMP or PZQ
- •Having taken other antimalarial or antischistosomal medication during the study.
- •Having participated in previous similar studies
结局指标
主要结局
Compare the parasite load between the two treatment arms
时间窗: After 28 days
Compare the amount of eggs produced between the two treatment arms
时间窗: After 28 days
Compare cure rate between the two treatment arms
时间窗: After 28 days
次要结局
- Evaluate changes in urine appearance before and after treatment(After 28 days)
- Evaluate changes in haematuria frequency before and after treatment(After 28 days)
研究者
研究点 (1)
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