NCT00465257暂停4 期
Efficacy of Artesunate + Amodiaquine Four Years After Its Introduction as New Treatment Policy for Uncomplicated Plasmodium Falciparum Malaria in Zanzibar
Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2007年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- PCR adjusted parasitological cure rate by day 42.
研究概览
简要总结
The purpose of this study is to assess the efficacy of artesuante + amodiaquine four years after its introduction as first line treatment for uncomplicated childhood malaria in Zanzibar. The hypothesis is that the treatment has a polymerase chain reaction (PCR)adjusted parasitological cure rate of at least 85% 42 days after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Age below 60 months
- •Weight ≥5kg
- •No general danger signs or severe malaria present (see 4.4.2.1 & 4.4.2.2)
- •History of fever within 24 hours OR axillary temperature ≥ 37.5Cº
- •No other cause of fever is detectable
- •No severe malnutrition
- •Presence of P. falciparum asexual parasite density between 2000- 200,000/ul
- •Guardian/Patient has understood the procedures of the study and is willing to participate
- •Patient able to come for stipulated follow up visits and has easy access to the Study Site
排除标准
- •Not able to drink or breastfeed
- •Persistent Vomiting
- •Recent history of convulsions
- •Lethargic or unconscious
- •Unable to sit or stand (as appropriate for age)
- •History of allergy to test drugs
- •History of intake of any drugs other than paracetamol and aspirin within 3 days
结局指标
主要结局
PCR adjusted parasitological cure rate by day 42.
次要结局
未报告次要终点
研究者
研究点 (1)
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