An Open Label Randomised Comparative Trial to Establish the Efficacy of 3 mg/kg ArTiMist™ When Compared to Intravenous Quinine in Children With Severe or Complicated Falciparum Malaria, or Uncomplicated Falciparum Malaria With Gastrointestinal Complications
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 主要终点
- Parasitological Success Defined as a Reduction in Parasite Count of ≥ 90% of Baseline at 24 Hours After the First Dose
研究概览
简要总结
The purpose of this study is to compare the efficacy of Artemether Sublingual Spray (ArTiMist™) with intravenous quinine in children with severe or complicated falciparum malaria, or children with uncomplicated malaria with gastrointestinal complications.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient's parent or attendant relative has provided informed consent and the patient has assented (where relevant) to participation in the trial
- •The patient is a child that weighs between 5 and 15 kg (kilogram)
- •The patient has falciparum malaria as evidenced by
- •Thick or thin blood smears of > 500 P falciparum per mcl (microlitre)(patients with mixed infections may be included provided >500 P Falciparum /mcl) and /or
- •Positive RDT (rapid diagnostic test)for malaria
- •The patient has either
- •severe or complicated malaria as determined by the Investigator based on the WHO criteria for severity, or
- •the patient has uncomplicated malaria but is unable to tolerate oral medication as a result of gastrointestinal complications such as vomiting or diarrhoea.
排除标准
- •Attending relative or parent does not provide informed consent for participation, or the child if capable does not assent to participation in the trial.
- •Ability to tolerate oral therapy
- •Patient has received any treatment with an artemisinin or quinine in the last 24 hours
- •Patient has evidence of significant co-infections (this does not include mixed Plasmodium infections).
- •Patient is allergic or intolerant to artemisinins.
研究组 & 干预措施
ArTiMist (artemether sublingual spray)
干预措施: Artemether (Drug)
Intravenous Quinine
干预措施: Quinine (Drug)
结局指标
主要结局
Parasitological Success Defined as a Reduction in Parasite Count of ≥ 90% of Baseline at 24 Hours After the First Dose
时间窗: 24 hours after first dose
Time for Parasite Count to Fall by 90% PCT(90)
时间窗: 3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h
The time taken for the parasite count to fall 90% from baseline
Time for Parasite Count to Fall by 50% PCT(50)
时间窗: 3 h (hours) , 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h
The time taken for the parasite count to fall 50% from baseline
次要结局
- Parasite Clearance Time(3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h)
- Parasite Reduction Ratio (PRR) at 24 h (Hours) After the First Dose(24 hours after first dose)
- Parasite Reduction Ratio (PRR) at 12 Hours After the First Dose(12 h (hours) after first dose)