A Multi-centre, Open-label, Non-comparative Study to Assess Safety and Clinical Response With Coartem® Baby Dispersible Tablets in Paediatric Patients (≥ 2 to <5 kg) With Uncomplicated Malaria Due to Plasmodium Falciparum or Mixed Infections
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
This study is being conducted to further evaluate the safety and clinical outcomes of Coartem® Baby (artemether/lumefantrine 5 mg/60 mg) in neonates and infants weighing ≥2 kg to <5 kg with uncomplicated malaria due to Plasmodium falciparum or mixed infections under real-world conditions.
详细描述
This is a multi-center, open-label, non-comparative study in neonates and infants (2 to < 5 kg) diagnosed with acute uncomplicated malaria due to Plasmodium falciparum or mixed infections including P. falciparum malaria. The study is being performed in response to requests from Swissmedic and African National Regulatory Authorities following the approval of Coartem® Baby, to generate additional post-marketing data in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female neonates/infants
- •Body weight ≥ 2 kg to < 5kg
- •Confirmed diagnosis of uncomplicated infections due to Plasmodium falciparum or mixed infections including P. falciparum malaria by RDT or microscopy.
- •Eligible to receive Coartem® Baby dispersible tablets as per approved label
排除标准
- •Participants with Coartem® Baby contraindications as per approved label.
- •Known hypersensitivity to artemether, lumefantrine or to any of the excipients of Coartem® Baby.
- •Patients with severe malaria according to WHO definition (See Appendix 3).
- •Patients with a family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to prolong the QTc interval such as patients with a history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease.
- •Patients taking drugs that are known to prolong the QTc interval
- •Any additional contraindications as per the approved label in the country
结局指标
主要结局
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
时间窗: Up to Day 29
Number of participants with AEs and SAEs, including changes in vital signs and clinical laboratory measurements qualifying and reported as AEs.
次要结局
- Proportion of patients with no malaria symptoms(From Day 7 to Day 29)
- Proportion of patients with positive parasitaemia(From Day 7 to Day 29)