NCT01619878已完成2 期
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
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Polymerase Chain Reaction (PCR) Corrected 28 Day Parasitological Cure Rate
研究概览
简要总结
The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data following treatment with artemether-lumefantrine dispersible tablet in infants < 5 kg of body weight (BW) with uncomplicated falciparum malaria.
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
- 性别
- All
- 接受健康志愿者
- 否
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
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.
研究组 & 干预措施
Cohort 1
Experimental
One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.
Infants age >28 days.
干预措施: Artemether-lumefantrine (COA566) (Drug)
结局指标
主要结局
Polymerase Chain Reaction (PCR) Corrected 28 Day Parasitological Cure Rate
时间窗: 28 days
Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 28, corrected for re-infection by Polymerase Chain Reaction (PCR) assay.
次要结局
- Polymerase Chain Reaction (PCR) Corrected Parasitological Cure Rate at Day 14 and 42(Day 14 and 42)
- Number of Participants With Parasitological Uncorrected Cure Rate at Day 3, 7, 14, 28 and 42(Day 3, 7, 14, 28 and 42)
- Percent Change of Parasite Count From Baseline at 24 Hours(baseline, 24 hours)
- Number of Participants With Parasitaemia at 48 Hours After Treatment Initiation Greater Than at Baseline(48 hours)
- Number of Participants With Parasitaemia at 72 Hours After Treatment Initiation Greater Than or Equal to 25 Percent of Count at Baseline(72 hours)
- Time to Parasite Clearance (PCT)(Up to 7 days)
- Time to Fever Clearance (FCT)(Up to 7 days)
- Time to Gametocyte Clearance (GCT)(Up to 7 days)
研究者
研究点 (2)
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