NCT02411994已完成3 期
Pyronaridine-artesunate and Artemether-lumefantrine for the Treatment of Paediatric Uncomplicated Falciparum Malaria in Western Kenya
Royal Tropical Institute1 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2015年10月最近更新:
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
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- PCR-corrected adequate clinical and parasitological response (ACPR)
研究概览
简要总结
The purpose of this study is to determine the efficacy of pyronaridine-artesunate and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between 6 months and 12 years old, with a body weight of ≥5 kg;
- •Living in the catchment area of the study (within a radius of ~10 km from St. Jude's Clinic, Mbita, Kenya);
- •Having microscopically confirmed P. falciparum mono-infection (asexual parasite density 1,000-200,000 µL-1).
排除标准
- •Signs and symptoms of severe malaria (according to WHO criteria for severe malaria, (WHO 2012)) or any other severe illness necessitating parenteral treatment;
- •Mixed Plasmodium infection;
- •Clinically suspected (oedema, jaundice and/or ascites) or reported hepatic and/or renal impairment (any cause, as reported by parents/guardians and/or evident from medical history);
- •Having anaemia with an Hb <6 g/dL;
- •Evidence of severe malnutrition (severe wasting: z-score weight for age <-3 and severe stunting: z-score height for age <-3 (WHO 2009b));
- •Having received anti-malarial therapy in the previous two weeks;
- •Known history of hypersensitivity, allergic or adverse reactions to artesunate, artemether-lumefantrine or other artemisinins;
- •Participating in other anti-malarial drug intervention studies;
- •Previous participation in the PAAL study, e.g. in the previous transmission season (each individual child can only take part in this study once);
- •Not being available for follow-up.
研究组 & 干预措施
Pyronaridine-artesunate
Experimental
pyronaridine-artesunate: recommended dose according to body weight, once a day for three days.
干预措施: Pyronaridine-artesunate (Drug)
Artemether-lumefantrine
Active Comparator
artemether-lumefantrine: recommended dose according to body weight, twice a day for three days.
干预措施: Artemether-lumefantrine combination (Drug)
结局指标
主要结局
PCR-corrected adequate clinical and parasitological response (ACPR)
时间窗: day 28 after initial dose
次要结局
- parasite clearance time(up to 7 days after initial dose)
- transmission potential to mosquitos(day 7 after initial dose)
- PCR-corrected adequate clinical and parasitological response (ACPR)(day 42 after initial dose)
- crude adequate clinical and parasitological response (ACPR)(day 28, day 42 after initial dose)
- gametocyte clearance time(up to 7 days after initial dose)
研究者
研究点 (1)
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