Phase 2a Dose Escalation Study of the Efficacy, Safety, and Pharmacokinetics of Low Dose Primaquine for Gametocytocidal Activity Against P. Falciparum in Sub-Saharan Africa and South East Asia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- mosquito infectivity assessed through membrane feeding
研究概览
简要总结
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of low single-dose primaquine for gametocidal activity against P.falciparum among adult glucose-6-phosphate dehydrogenase (G6PD)-normal malaria patients.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age >= 18 years and < 50 years
- •Malaria blood thick film positive
- •Presence of gametocytes on thick blood film
- •Agrees to admission to study ward for 26 hours post diagnosis and available for follow up visits
- •No allergies to study drugs
- •Hemoglobin >= 8 g/dl
- •No evidence of severe or chronic disease
- •Written, informed consent
排除标准
- 未提供
研究组 & 干预措施
dihydroartemisinin-piperaquine only
dihydroartemisinin -piperaquine (DP) only
干预措施: dihydroartemisinin-piperaquine (Drug)
DP and 0.125 mg/kg primaquine
DP and single dose oral 0.125 mg/kg primaquine
干预措施: dihydroartemisinin-piperaquine (Drug)
DP and 0.125 mg/kg primaquine
DP and single dose oral 0.125 mg/kg primaquine
干预措施: 0.125 mg/kg Primaquine (Drug)
DP and 0.5 mg/kg primaquine
DP and single dose oral 0.5 mg/kg primaquine
干预措施: dihydroartemisinin-piperaquine (Drug)
DP and 0.5 mg/kg primaquine
DP and single dose oral 0.5 mg/kg primaquine
干预措施: 0.5 mg/kg Primaquine (Drug)
DP and 0.25 mg/kg primaquine
DP and a single dose oral 0.25 mg/kg primaquine
干预措施: dihydroartemisinin-piperaquine (Drug)
DP and 0.25 mg/kg primaquine
DP and a single dose oral 0.25 mg/kg primaquine
干预措施: 0.25 mg/kg Primaquine (Drug)
DP and 0.0625 mg/kg primaquine
DP and a single dose oral 0.0625 mg/kg primaquine
干预措施: dihydroartemisinin-piperaquine (Drug)
DP and 0.0625 mg/kg primaquine
DP and a single dose oral 0.0625 mg/kg primaquine
干预措施: 0.0625 mg/kg Primaquine (Drug)
结局指标
主要结局
mosquito infectivity assessed through membrane feeding
时间窗: 7 days
Baseline, Days 1, 2, 7
次要结局
- gametocyte prevalence and density(28 days)
- primaquine pharmacokinetics - area under the curve (AUC) of parent drug and metabolite(24 hours)
- asexual parasite prevalence and density(28 days)
- safety measurements including hemoglobin and signs of hemolysis(28 days)