CTRI/2011/06/001849已完成3 期
A bridging study comparing efficacy and safety of novel formulation of artesunate injection in treatment of Plasmodium falciparum malaria
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Cure Rate
研究概览
简要总结
This study is a randomized, double blind, parallel group multicenter trial comparing safety and efficacy of artesunate injection in the treatment of Plasmodium falciparum malaria. The primary efficacy outcome measure will be 28-day cure rate and the secondary efficacy outcome measure will be fever clearance time and parasite clearance time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female subjects in the age range of 18-65 years (both inclusive)
- •Satisfactory medical assessment with no clinically significant or relevant abnormalities except for study related disease condition.
- •Patients with signs and symptoms of malaria and confirmation of diagnosis by positive blood smear test with asexual forms of Plasmodium falciparum with count equal to or more than 10,000 parasites per ul of blood and requiring parenteral therapy
- •Patient must understand and be able, willing, and likely to fully comply with study procedures and restrictions
- •Patient willing to come for study follow up as required by study protocol.
排除标准
- •Patients with febrile disease other than malaria
- •Patients with mixed malarial infections
- •Patient with severe malaria
- •Patients with abnormal heart function
- •Pregnant or lactating women.
- •Women of childbearing potential not practicing contraception.
结局指标
主要结局
Cure Rate
时间窗: 28-day
次要结局
- Fever Clearence Time(Every 6 hours)
- Parasite Clearence Time(Every 12 hours)
研究者
研究点 (6)
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