Parenteral Artesunate Compared to Quinine as a Cause of Late Post-treatment Anaemia in African Children With Hyperparasitaemic P. Falciparum Malaria
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- Late onset anaemia
研究概览
简要总结
Delayed anaemia has been reported in European travellers with malaria cured by artesunate. Although no deaths related to this delayed anaemia have been reported so far, blood transfusion has been necessary in some affected patients. Recent observations suggest that this episodes of anaemia also occurs in endemic countries. The aim of this trial is to assess the incidence of late onset anaemia after treatment with intravenous artesunate compared to intravenous quinine, to identify patients at risk and to clarify the causes of this delayed anaemia.
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
- 年龄范围
- 6 Months 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 6 months and ≤ 14 years
- •Acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of P. falciparum or mixed with non-falciparum species
- •Asexual P. falciparum parasitaemia ≥ 100,000/uL and ≤500,000/uL
- •Haemoglobin ≥5.0 g/dL
- •Parents/guardians agree to hospitalize the child for the length of treatment (3 days) and bring the patient for planned follow-up visits at day 7, 14, 21, 28, 35, 42
- •Signed consent from the guardian/parents
排除标准
- •Body weight ≤ 5 kg
- •Severe malaria or signs of severe malaria as defined by WHO Guidelines 2013
- •History of hypersensitivity or contraindication to quinine or artesunate
- •A clear history of adequate antimalarial treatment in the preceding 24 hours with drugs expected to be effective
- •Presence of intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the patient treatment or results of the study
- •Participation in another clinical trial
研究组 & 干预措施
IV artesunate
Intravenous artesunate 2.4 mg/kg body weight STAT, then 2.4 mg/kg at 12, 24, 48 and 72 hours (5 doses total)
干预措施: artesunate (Drug)
IV quinine
Intravenous quinine dihydrochloride 20 mg salt/kg body weight loading dose over 4 hours, then 10 mg/kg over 2 hours 8 hourly until 72 hours (9 doses total)
干预措施: quinine (Drug)
结局指标
主要结局
Late onset anaemia
时间窗: Patients are hospitalized for 4 days or longer if still unwell. After discharge the follow-up consists of 6 weekly visits (time frame 42 days). Late anaemia is measured between 7 and 42 days following the start of antimalarial treatment
Late onset anaemia in this study is defined as a ≥10% drop in haemoglobin on any previous measurement anytime between day 7 and 42
次要结局
未报告次要终点