CTRI/2009/091/000434已完成3 期
Comparative evaluation of efficacy and safety of artesunate-lumefantrine vs. artemether-lumefantrine fixed dose combination in the treatment of uncomplicated Plasmodium falciparum malaria.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 6
- 主要终点
- Adequate Clinical and Parasitological Response
研究概览
简要总结
This study is a randomised, double blind, parallel group, multicentre trial comparing the safety and efficacy of artesunate 100 mg + lumefantrine 480 mg with artemether 80 mg + lumefantrine 480 mg in the treatment of Indian patients with uncomplicated Plasmodium falciparum malaria. The patients will be hospitalized for 4 days. The follow up period is of 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
入选标准
- •Male and female patients with age between 18 to 65 years
- •Patients clinically diagnosed of uncomplicated Plasmodium falciparum malaria with a diagnosis confirmed by positive blood smear with asexual forms of P.
- •falciparum (parasite count between 1000 and 100,000 asexual parasites/µL of blood)
- •Patients with axillary temperature >/= 37.5 °C and/or history of fever during past 24 hours
- •Patients with clinical signs and symptoms of malaria
- •Patients with satisfactory medical assessment with no clinically significant or relevant abnormalities except for study related disease condition.
排除标准
- •Patients with severe malaria as per WHO criteria
- •Patients with mixed malarial infection
- •Patients with abnormal heart function including history of QTc prolongation
- •Patients receiving any concomitant medication which may interact with study drugs
- •Patients who had taken full course of antimalarials within previous 3 days
- •Pregnant or lactating women
- •Women of child bearing potential.
结局指标
主要结局
Adequate Clinical and Parasitological Response
时间窗: Day 28
次要结局
- Parasite Clearance Time(Day 1, Day 2 and Day 3)
- Fever Clearance Time(Day 1, Day 2 and Day 3)
研究者
研究点 (6)
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