A Randomized Trial of the Efficacy of Artesunate and Three Quinine Regimens in the Treatment of Severe Malaria in Children at the Ebolowa Regional Hospital - Cameroon
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 238
- 主要终点
- Fever clearance time
研究概览
简要总结
The purpose of the study is to evaluate and compare the efficacy of parenteral artesunate with three quinine regimens in the treatment of severe malaria in children at the Ebolowa Regional Hospital located in the South region of Cameroon
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
- 3 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children presenting with one or more signs of severity of malaria according to the 2013 Cameroon National Malaria Control Programme adopted criteria (impaired consciousness, abnormal behaviour, convulsions, prostration, persistent vomiting, jaundice, hyperthermia, acute respiratory distress, clinical acidosis, haemoglobinuria, cardiovascular shock, dehydration, abnormal bleeding, severe anaemia, renal impairment, hypoglycaemia and hyperparasitaemia)
- •and having an initial positive parasitaemia to Plasmodium falciparum
- •Other aetiologies of the presenting symptoms excluded
- •Written consent from parent(s)
排除标准
- •Prior side effects to either artesunate or quinine administration
- •Severely malnourished children
- •Concomitant infection
研究组 & 干预措施
ARTES
- Injectable Artesunate.Each vial contained 60 mg anhydrous artesunic acid, which was dissolved in 1 ml of 5% sodium bicarbonate (provided with the drug) and then mixed with 5 ml saline solution (provided with the drug) before injecting into an indwelling intravenous catheter.
- Patients received 2.4 mg/kg bw of parenteral artesunate at H0, H12, H24 and thereafter once daily, for a minimum of 24 hours.
- Patients exited from the protocol if they had clinically recovered and parasitaemia was negative.
干预措施: Artesunate (Drug)
QLD
- Injectable quinine. Each vial contained 250 mg or 500 mg QB.
- Patients received a loading dose of 16.6 mg/kg bw of QB by intravenous (IV) infusion over 4 hours followed 8 hours after the start of the loading dose, with a maintenance dose of QB at 8.3 mg/kg bw over 4 hours every 8 hours diluted in 10 ml/kg bw of 10% dextrose solution.
- Patients received a minimum of 24 hours of parenteral treatment and exited from the protocol if they had clinically recovered and parasitaemia was negative.
干预措施: Quinine (Drug)
QNLD3
- Injectable quinine. Each vial contained 250 mg or 500 mg QB.
- Patients received 8.3 mg/kg bw of QB over 4 hours by IV infusion every 8 hours diluted in 10 ml/kg bw of 10% dextrose solution.
- Patients received a minimum of 24 hours of parenteral treatment and exited from the protocol if they had clinically recovered and parasitaemia was negative.
干预措施: Quinine (Drug)
QNLD2
- Injectable quinine. Each vial contained 250 mg or 500 mg QB.
- Patients received 12.5 mg/kg bw of QB over 4 hours by IV infusion every 12 hours diluted in 10 ml/kg bw of 10% dextrose solution.
- Patients received a minimum of 24 hours of parenteral treatment and exited from the protocol if they had clinically recovered and parasitaemia was negative.
干预措施: Quinine (Drug)
结局指标
主要结局
Fever clearance time
时间窗: Time (in hours) from the onset of treatment till rectal temperature went down to 37.5°C for at least 24 hour
Parasite clearance time
时间窗: Time (in hours) from the onset of treatment to the time of the first of two successive negative blood smear through hospital discharge, an average of one week
Time to sit unsupported
时间窗: Time (in hours) from the onset of treatment till when the participant could sit unsupported for an average of 24 hours if the participant was unable to do so on admission
Parasite reduction rate 24 hours after onset of treatment
时间窗: 24 hours from onset of treatment
Coma recovery time
时间窗: Time (in hours) from the onset of treatment till the participant was fully conscious with a BCS of 5 or GCS of 15 for an average of 24 hours
Time to eat and drink
时间窗: Time (in hours) from the onset of treatment till when the participant could eat and drink for an average of 24 hours if the participant was unable to do so on admission
次要结局
未报告次要终点
研究者
ETHE MAKA Daniel
MD
University of Yaounde 1