Pharmacokinetics of Dihydroartemisinin-Piperaquine in the Treatment of Uncomplicated Malaria in Children in Burkina Faso
试验速览
- 阶段
- 4 期
- 状态
- 已完成
研究概览
简要总结
This will be an open-label trial in Burkina Faso assessing the pharmacokinetics of the antimalarial combination of dihydroartemisinin/piperaquine (DP, Duocotexcin) in children. Dihydroartemisinin-piperaquine is a promising candidate for first-line therapy of malaria. We hypothesize that the disposition and pharmacokinetics of DP will be altered in children, and this will alter the efficacy and/or toxicity of DP. We will test this hypothesis in this open-label trial in Burkina Faso. The target population includes residents, aged 6 months to 10 years in Bobo-Dioulasso. Children who present to the study clinics with symptoms suggestive of malaria will be screened with a thick blood smear. Subjects who meet selection criteria of treatment efficacy will be treated and followed up for 42 days. Pharmacokinetic sampling for DP will occur on selected follow-up days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive screening thick blood smear
- •Fever (> 37.5ºC axillary) or history of fever in the previous 24 hours
- •Age ≥ 6 months to 10 years
- •Weight > 5 kg
- •Absence of any history of serious side effects to study medications
- •No evidence of a concomitant febrile illness in addition to malaria
- •No history of antimalarial use in the previous two weeks
- •P. falciparum mono-infection
- •Parasite density 2000-200,000/ul
- •Provision of informed consent and ability to participate in 42-day follow-up
排除标准
- •Danger signs or evidence of severe malaria
- •Hemoglobin levels < 5.0 gm/dL
研究者
Sunil Parikh
Assistant Professor
University of California, San Francisco