Effectiveness and Safety Evaluation of the Riamet® Versus Malarone® in the Treatment of Uncomplicated Malaria : a Multicentric Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 317
- 试验地点
- 1
- 主要终点
- Number of cases where a second line treatment is used for either intolerance or lack of effectiveness
研究概览
简要总结
Riamet® or Malarone® are both recommended as the first line treatment for uncomplicated malaria in France, according to the French consensus Conference revised in 2007 on the treatment of imported malaria.
The aim of the study is to compare both tolerance and efficacy of Malarone® and Riamet® in the treatment of uncomplicated imported malaria and to determine clinical and parasitological predictive factors associated with a less effectiveness. It's a multicentric, randomised study in adults with uncomplicated malaria. Treatment will be administered for 3 days, and patients will be followed for 28 days, to evaluate the therapeutic evolution. 640 patients will be included among 15 centres.
详细描述
Background : RIAMET® or Malarone® are both recommended as the first line treatment for uncomplicated malaria in France, according to the French consensus Conference revised in 2007 on the treatment of imported malaria. Today no randomized controlled trial (RCT) comparing both treatments are available for either tolerance or efficacy especially in the field of imported malaria.
Malarone®, an atovaquone+proguanil combination, has become these last years the most prescribed treatment in adult in this indication in France. With Malarone®, therapeutic failures are rare, but digestive side effects are observed, such as vomiting, possibly leading to the use of a second line treatment.
Riamet®, an artemether+lumefantrine combination, is available in France since only July 2007, but is largely used in endemic areas (as CO-ARTEM). A good tolerance and efficacy are reported by studies performed in endemic areas.
Both antimalarials are to be taken for a 3-days treatment period, once a day for Malarone®, but twice a day for Riamet®, which is supposed to affect the observance, on the one hand. On the other hand, parasitological cure rate and apyrexia occur faster with RIAMETt® than with Malarone®.
Primary objective: to compare both tolerance et efficacy of Malarone® and RIAMET® in the treatment of uncomplicated imported malaria.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects aged more than 18,
- •back from an endemic area with a positive diagnosis of Plasmodium falciparum by microscopic blood (thin and thick film) examination,
- •absence of any severe manifestation according to the WHO definition of severe falciparum malaria
- •EXCLUSION CRITERIA:
- •pregnancy,
- •ECG abnormality,
- •contraindication to treatment,
- •previous anti-malaric treatment within 30 days,
- •unable to come back at J3, J7 and J28,
- •unwilling to consent to participate
排除标准
- 未提供
研究组 & 干预措施
Malarone
Malarone (atovaquone + proguanil combination):
patients treated with Malarone®
干预措施: Malarone (atovaquone + proguanil combination) (Drug)
Riamet
RIAMET (artemether + LUMEFANTRIN combination):
patients treated with Riamet®
干预措施: RIAMET (artemether + LUMEFANTRIN combination) (Drug)
结局指标
主要结局
Number of cases where a second line treatment is used for either intolerance or lack of effectiveness
时间窗: within the 28 days after diagnosis of malaria
次要结局
- Parasitological cure rate(At day 3)
- Fever clearance(At day 3)
- Number of relapses(At day 3)
- Digestive tolerance(At day 3)