Artemether-lumefantrine Vs Co-formulated Amodiaquine + Artesunate for the Treatment of Uncomplicated Falciparum Malaria: a Randomized Open-label Trial to Evaluate the Effectiveness of the Burkina Faso New Drug Policy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Centre Muraz
- 入组人数
- 340
- 试验地点
- 3
- 主要终点
- Polymerase chain reaction (PCR) adjusted treatment failure
研究概览
简要总结
Several countries in Africa have changed their first-line treatment for uncomplicated malaria to an ACT. Burkina Faso has changed its policy to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS). However, such choice has been done without knowing the local effectiveness of these drugs when they are given to patients in real life conditions, without direct observation of the drug administration. Thus, this study aims at investigating the effectiveness of AQ+AS and AL, when given to children with uncomplicated malaria in Burkina Faso.
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 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight > 5 kg;
- •Monoinfection with P. falciparum and a parasitaemia of 2,000-200,000 parasites /µl;
- •Fever (axillary temperature ≥37.5 °C) or history of fever in the preceding 24 hours;
- •Haemoglobin value above 5.0 g/dl;
- •Absence of febrile conditions caused by diseases other than malaria.
排除标准
- •Danger signs: not able to drink or breast-feed, vomiting (> twice in 24hours), recent history of convulsions (>1 in 24h), unconscious state, unable to sit or stand;
- •Signs of severe malaria (WHO 2000);
- •Mixed malaria infection;
- •Severe malnutrition;
- •Other underlying diseases (cardiac, renal, hepatic diseases);
- •History of allergy to study drugs;
研究组 & 干预措施
Artemether -lumefantrine
Experimental Treatment of malaria with Artemether-lumefantrine (AL), according to one of the two options given by national protocol in Burkina Faso
干预措施: Artemether-lumefantrine (Drug)
Artesunate-amodiaquine
Treatment of malaria with Artesunate-amodiaquine(AS-AQ), according to one of the two options given by national protocol in Burkina Faso
干预措施: Artesunate-amodiaquine (Drug)
结局指标
主要结局
Polymerase chain reaction (PCR) adjusted treatment failure
时间窗: Day 28
次要结局
- Treatment failure up to day 42 (PCR adjusted and unadjusted)(Day 42)
- Gametocytes (prevalence and density)(At day 7, 14, 21, 28, 35 and 42 days after treatment)
- Hb changes(Day 35)