A Comparative Assessment of the Efficacy of Fosmidomycin-Clindamycin Versus Sulfadoxine-Pyrimethamine for the Treatment of Children With Uncomplicated Plasmodium Falciparum Malaria
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Clinical and parasitological cure rate by day 28
研究概览
简要总结
There is a necessity for the development of new malaria drugs. Some antibiotics are also effective against malaria parasites. Fosmidomycin is an antibiotic that has been shown to be effective against malaria, although it cannot achieve a total cure in all patients. Previous small studies have shown that in combination with clindamycin, an commonly used antibiotic, it is highly effective and safe when given for three days, leading to a total cure in most patients. The current study will evaluate its efficacy in a larger population in Gabon, and compare its effect with the generally used drug, sulfadoxine-pyrimethamine.
详细描述
Fosmidomycin-clindamycin (30 mg/kg and 10 mg/kg) given twice daily for three days is an effective and safe combination of antibiotics which demonstrated good activity against malaria parasite in previous phase II studies in African children. In this phase III trial, the efficacy and safety of the combination will be evaluated in African children with uncomplicated P. falciparum malaria. A single dose of sulfadoxine-pyrimethamine, the standard antimalarial in Gabon, is used as comparator.
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 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Uncomplicated P. falciparum malaria
- •P. falciparum asexual parasitaemia between 1,000/µL and 100,000/µL
- •Body weight between 10 - 65 kg
- •Ability to tolerate oral therapy
- •Informed consent, oral assent of the child, if possible
- •Residence in study area
排除标准
- •Adequate anti-malarial treatment within the previous 7 days
- •Antibiotic treatment for the current infection
- •Previous participation in this clinical trial
- •Haemoglobin < 7 g/dl
- •Haematocrit < 23 %
- •Leucocyte count > 15,000 /µL
- •Mixed plasmodial infection
- •Severe malaria (as defined by WHO)
- •Any other severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection)
- •Concomitant disease masking assessment of response
- •History of allergy or intolerance against trial medication
结局指标
主要结局
Clinical and parasitological cure rate by day 28
次要结局
- Safety and tolerability of the two treatments during the entire study period
- Parasite clearance time
- Fever clearance time