EUCTR2011-005852-33-Outside-EU/EEA进行中（未招募）不适用
An open-label, single-arm study to evaluate the efficacy, safety and PK of artemether-lumefantrine Dispersible Tablet in the treatment of acute uncomplicated Plasmodium falciparum malaria in infants <5 kg Body Weight
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Neonates / infants
- •Body weight < 5 kg
- •In cohort 1, infants aged > 28 days; in cohort 2, neonates of a term age 0 to = 28 days
- •Microscopically confirmed diagnosis of acute uncomplicated Plasmodium falciparum malaria or mixed infections with an asexual Plasmodium falciparum parasitaemia of > 1,000 and < 100,000 parasites/µL
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Presence of severe malaria (according to World Health Organization definition)
- •Presence of the following signs of a critical condition: apnea-bradycardia, sustained bradycardia, tachycardia, desaturation, hypotension, hypothermia; or other severely deteriorated general condition (based on IMCI criteria in sick infants)
- •Presence of any clinically significant neurological condition
- •Presence of clinically significant abnormality of the hepatic and renal systems
- •Patients who sustained a significant blood volume loss (> 3% of calculated blood volume) in the past 30 days
- •Patients unable to swallow or whose drinking is impaired
- •Family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to be associated with prolongation of the QTc interval such as history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease
- •Disturbances of electrolyte balance (e.g. hypokalaemia or hypomagnesaemia)
- •Presence of any age-adjusted clinically or hematologically relevant laboratory and blood chemistry abnormalities
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究者
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