NCT00529867已完成4 期
A Randomized Open-Label Trial of the Efficacy of Artemether-Lumefantrine Suspension Compared With Artemether-Lumefantrine Tablets for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Less Than Five Years in Western Kenya
Dafra Pharma1 个研究点 分布在 1 个国家目标入组 267 人开始时间: 2007年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 267
- 试验地点
- 1
- 主要终点
- To compare PCR corrected cure-rates on day 14 and 28
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy in children aged 6 - 59 months with uncomplicated malaria, treated with either conventional artemether/lumefantrine tablets(Coartem®) or artemether/ lumefantrine suspension (Co-artesiane®) in Western Kenya
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
- 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
- •Children aged between 6 and 59 months
- •Minimum body weight of 5kg
- •Presence of fever (Temp >/= 37.5°C) or a history of fever in the last 24 hours
- •Presence of asexual P. falciparum monoinfection
- •Initial parasite density of between 2,000 and 200,000 asexual parasites/µl of blood
- •Not suffering from severe and complicated forms of malaria
- •Able to take drugs under study by the oral route
- •Parent or guardian gives informed written consent to participate in study
排除标准
- •Severe and/or complicated malaria (WHO, 2000 classification), including severe anaemia (Hb =/<5 g/dl), two or more seizures in last 24 hrs and hyper-parasitaemia (>200,000 µl)
- •Patients treated with mefloquine, halofantrine within the 7 days before Day 0 or with quinine salts and artemisinin derivatives within 3 days before Day 0, or artemether-lumefantrine 30 days before Day 0
- •Patients who require intensive care for malaria or another severe concomitant illness capable of interfering with the clinical evolution of malaria
- •Patients with vomiting and/or diarrhoea
- •Signs of severe malnutrition (defined as follows: children with weight/height ratio below 3 standard deviations or below 70% of the median of the WHO standardized reference values, or still with symmetrical oedema affecting both feet)
- •Presence of general danger signs in children below 5 years or other signs of serious and complex Plasmodium falciparum, as stated in the present WHO definitions
- •Patients with known history of heart disease or arrhythmia
- •History of allergy to artemether/lumefantrine or quinine
研究组 & 干预措施
A
Active Comparator
干预措施: Artemether/lumefantrine tablets (Drug)
B
Active Comparator
干预措施: Artemether/Lumefantrine suspension (Drug)
结局指标
主要结局
To compare PCR corrected cure-rates on day 14 and 28
时间窗: 1 year
次要结局
- Monitor any possible adverse reactions following use of both drugs(28 days)
- To determine and compare Adequate Clinical and Parasitological Response (ACPR) at days 14 and 28(28 days)
- To determine and compare proportion of children with gametocytes on days 0, 7, 14, and 28(28 days)
研究者
研究点 (1)
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