NCT00454961已完成4 期
Effectiveness of Artemether-Lumefantrine Treatment Provided by Community Health Worker Against Uncomplicated Malaria in Children Under 5 Years of Age in Tanzania
Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2007年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Effectiveness (PCR adjusted parasitological cure rate) of artemether-lumefantrine
研究概览
简要总结
The purpose of this clinical trial is to assess the effectiveness of artemether-lumefantrine (Coartem®) treatment provided by community health workers against uncomplicated malaria in children under 5 years of age in Kibaha District, Tanzania, during an extended follow-up of 42 days. The hypothesis is that artemether-lumefantrine treatment provided by community health workers will result in less than 85% PCR-corrected parasitological effectiveness by day 42, mainly due to partial non-compliance to full standard 6-dose regimen of the drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged <5 years
- •Weight >5 kg
- •Suffering from acute uncomplicated P. falciparum malaria confirmed by RDT. Later microscopy using Giemsa-stained thick film will be made to ensure asexual parasite density of 2000 to 200 000 parasites/µL
- •Having a history of fever in the preceding 24 h
- •Able to ingest tablets orally
- •Willing and able to attend stipulated follow-up visits
- •With written informed consent from parent/guardian for children to participate in the trial.
排除标准
- •Presenting with any of the following "danger signs of severe malaria":
- •Convulsions (>1 episode within previous 24 hours)
- •Lethargic/unconscious
结局指标
主要结局
Effectiveness (PCR adjusted parasitological cure rate) of artemether-lumefantrine
during 42 days follow-up.
次要结局
未报告次要终点
研究者
研究点 (1)
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