A Phase III, Randomised, Open Labelled, Active Controlled, Multi Centre, Superiority Trial of ArTiMist™ Versus Intravenous Quinine in Children With Severe or Complicated Falciparum Malaria, or Uncomplicated Falciparum Malaria With Gastrointestinal Complications.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 3
- 主要终点
- Parasitological Success (MITT)
研究概览
简要总结
The purpose of this study is to demonstrate that ArTiMist (sublingual artemether spray) is better than intravenous quinine in reducing parasite counts by >= 90% within 24 hours after the start of treatment in children with severe malaria, or uncomplicated malaria with gastrointestinal complications
详细描述
Malaria causes significant morbidity and mortality in children in developing countries, despite the availability of highly effective antimalarial therapy. One of the key contributing factors is the delay in the initiation of treatment.
ArTiMist is a sublingual formulation of the established antimalarial treatment, artemether. In previous studies good bioavailability has been demonstrated. In an exploratory study (ART003) ArTiMist demonstrated a non statistically significant improvement of 26% (when compared to intravenous quinine) in the numbers of patients experiencing a parasite reduction of >= 90% within 24 hours of the initiation of treatment.
This Phase 3 study is being conducted to establish whether treatment with ArTiMist in children with severe falciparum malaria or uncomplicated falciparum malaria with gastrointestinal complications is at least 20% superior in providing parasitological success (defined as >= 90% reduction in parasite count at 24 hours after start of treatment) when compared to intravenous quinine.
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 legally acceptable representative has provided informed consent and the patient has assented (where relevant) to participation in the trial
- •The patient is a child that weighs between 5.00 kg and 15.00 kg inclusive
- •The patient has falciparum malaria as evidenced by thick or thin blood smears of ≥ 500 P Falciparum per mcl (patients with mixed infections may be included provided ≥ 500 P Falciparum per mcl)
- •The patient has either:
- •severe or complicated falciparum malaria as determined by the investigator based on the WHO criteria for severity, and/or
- •uncomplicated falciparum malaria but is unable to tolerate oral medication as a result of gastrointestinal complications such as vomiting or diarrhoea.
排除标准
- •The patient's legally acceptable representative 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 antimalarial therapy within the 7 days prior to first study drug administration.
- •Patient has evidence of significant co-infections (this does not include mixed Plasmodium infections).
- •Patient has a contraindication, allergy or is otherwise intolerant to either artemether or quinine .
研究组 & 干预措施
ArTiMist
干预措施: Artemether Sublingual Spray (Drug)
Quinine
干预措施: Quinine (Drug)
结局指标
主要结局
Parasitological Success (MITT)
时间窗: 24 hours after start of treatment
Parasitological success defined as a reduction in parasite count of ≥ 90% of baseline at 24 hours after the first dose
Parasitological Success (PP)
时间窗: 24 hours after start of treatment
Parasitological success defined as a reduction in parasite count of ≥ 90% of baseline at 24 hours after the first dose
次要结局
- Parasite Clearance Time (PCT) [MITT Population](28 days after start of treatment)
- PCT 90 [MITT Population](28 days after start of treatment)
- PCT 50 [MITT Population](28 days after start of treatment)
- PRR 24 [MITT Population](28 days after start of treatment)
- PRR 12 [MITT Population](28 days after start of treatment)
- Fever Clearance Time (FCT)(28 days after start of treatment)
- Complete Cure Rate(28 days after the start of treatment)
- Early Treatment Failure(Three days after the start of treatment)
- Late Clinical Failure(28 days after the start of treatment)
- Late Parasitological Failure(28 days after the start of treatment)
- Time to Return to Full Consciousness(28 days after start of treatment)
- Time to Return to Normal Per os Status(28 days after start of treatment)
- Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events, of Possible, Probably and Definite Causalities(28 days after start of treatment)
- Number of Deaths or Neurological Sequelae at Day 28(28 days after start of treatment)