NCT00367653已完成3 期
A Phase 3, Randomized, Open-Label, Comparative Trial Of Azithromycin Plus Chloroquine Versus Mefloquine For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In Africa
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 397
- 试验地点
- 1
- 主要终点
- The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is noninferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in Africa.
研究概览
简要总结
To compare Azithromycin plus Chloroquine versus Mefloquine to treat uncomplicated plasmodium falciparum malaria.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females and males 18 years of age and older with uncomplicated, symptomatic malaria as as indicated by the presence of both of the following:
- •Blood smears positive for Plasmodium falciparum asexual parasitemia between 1000 -100,000 parasites
- •Documented fever (38.5 C/101.3 F rectal or tympanic; 37.5 C/99.5 F axillary or 38 C/100.4 F oral) or history of fever (as reported by subject) within the prior 24 hours.
排除标准
- •Severe or complicated malaria.
- •Pregnant or breast-feeding women.
研究组 & 干预措施
1
Experimental
干预措施: Azithromycin plus Chloroquine (Drug)
2
Experimental
干预措施: Mefloquine (Drug)
结局指标
主要结局
The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is noninferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in Africa.
时间窗: duration of trial
The primary endpoint of the study will be the asexual P. falciparum Parasite Clearance Rates (adjusted for molecular testing determining recrudescence, true failures, from reinfection, true cures) at Day 28 in the Parasitologic Per Protocol population.
时间窗: duration of trial
次要结局
- A secondary objective is to assess the efficacy of azithromycin plus chloroquine.(duration of trial)
- Additional secondary objectives include an assessment of the safety and tolerability of all treatment regimens.(duration of trial)
研究者
研究点 (1)
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