A Phase 2, Open Label, Non-Comparative Trial Of Azithromycin 2000 mg Plus Chloroquine 600 Mg Base Daily For Three Days For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Parasite Clearance at Day 28
研究概览
简要总结
The treatment of symptomatic, uncomplicated malaria caused by P. falciparum in adults.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females greater then or equal to the age of 18 with uncomplicated, symptomatic malaria as indicated by the presence of blood smears positive for P. falciparum asexual parasitemia between 1000-100,000 parasites/uL and documented fever greater then or equal to 38.5 C/101.3 F rectal or fever greater then or equal to 38 C/100.4 F oral or history of fever as reported by subject within the prior 24 hours.
排除标准
- •Subjects with severe or complicated malaria. Pregnant or breast feeding women.
研究组 & 干预措施
Azithromycin plus chloroquine
Single Arm, Open label study
干预措施: Azithromycin plus chloroquine (Drug)
结局指标
主要结局
Percentage of Participants With Parasite Clearance at Day 28
时间窗: Day 28
Parasite clearance was defined as the clearance of asexual Plasmodium falciparum (P falciparum) parasitemia (defined as three consecutive 0 parasite counts) within 7 days of initiation of treatment, without subsequent recrudescence up to Day 28. Failure to achieve clearance of asexual P falciparum parasitemia was defined as parasitemia not cleared within 7 days of initiation of treatment, or subsequent recrudescence (confirmed by molecular testing) by Day 28 after achieving clearance. Percentage of participants with clearance is reported. Here "N" (Number of participants analyzed) signify participants who were evaluable (parasitological per protocol) at Day 28.
次要结局
- Percentage of Participants With Late Treatment Failures (LTF)(Baseline up to Day 28)
- Percentage of Participants With Parasite Clearance at Day 7, 14, 21, 35, 42(Day 7, 14, 21, 35, 42)
- Percentage of Participants With Early Treatment Failures (ETF)(Baseline up to Day 28)
- Percentage of Participants With Resistance to Treatment(Days 7, 14, 21, 28, 35, 42)
- Percentage of Participants With Clinical Cure(Day 3, 7, 28, and 42)
- Percentage of Participants With Gametocyte Clearance(Day 7, 14, 21, 28, 35, 42)
- Fever Clearance Time(Baseline up to Day 42)
- Parasite Clearance Time(Baseline up to Day 42)