Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Day 28 cure rate >95%
研究概览
简要总结
This is an open label uncontrolled study to determine the efficacy of fosmidomycin and clindamycin when co-administered orally over three days in the treatment of acute uncomplicated Plasmodium falciparum malaria in children.
The primary study endpoints will be the cure rate on Day 28 (PCR corrected). The secondary endpoints will be the cure rate on Day 7 and the parasite and fever clearance times.
详细描述
An open label uncontrolled study to determine the efficacy of fosmidomycin and clindamycin when co-administered orally over three days in the treatment of acute uncomplicated Plasmodium falciparum malaria in children.
The primary study endpoints will be the cure rate on Day 28 (PCR corrected). The secondary endpoints will be the cure rate on Day 7 and the parasite and fever clearance times.
Study population A total of 40 children will be recruited into the study. Sample size calculations have been made on the basis that this trial aims at substantiating the efficacy results obtained in children in Gabon. In the largest trial of this drug combination done in Gabon, 51 children were recruited, and the per-protocol, PCR-adjusted day 28 cure rate was 89% (42/47; 95% CI, 77 to 96%). Based on this expected 90% efficacy estimate, a sample size of 35 children produces a two-sided 95% confidence interval with a an estimated precision of 20%.
Allowing for an attrition rate of 10% for non-evaluable subjects, a sample size of 40 subjects will be required.
Study endpoints Primary The primary endpoint will be the cure rate on Day 28 (PCR corrected). Secondary The secondary endpoints will be the cure rate on Day 7 and the parasite and fever clearance times.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male subjects aged six months to three years
- •Female subjects aged six months to three years
- •Body weight >5kg
- •Acute (symptoms lasting less than 14 days) uncomplicated P falciparum malaria
- •Asexual parasitaemia between 1,000/µL and 200,000/µL
- •Ability to tolerate oral therapy
- •Willingness of the parent or guardian to provide informed signed consent
排除标准
- •Symptoms/signs of severe malaria, according to WHO criteria
- •Body weight <5kg
- •Other plasmodial infections (P vivax, P ovale, P malariae)
- •Severe malnutrition with weight for age <60% or clinical kwashiorkor
- •Gastro-intestinal disturbance with persistent vomiting (> three episodes within previous 24 hours) and/or diarrhoea (> 5 loose stools in the preceding 24 hours)
- •Concomitant disease masking assessment of response including sickle cell disease and severe cardiac, hepatic or renal impairment
- •Haemoglobin <7g/dl
- •Adequate anti-malarial treatment within previous 7 days
- •Inability to tolerate oral therapy
- •Parent or guardian deemed to be unsupportive
- •On co-trimoxazole prophylaxis
研究组 & 干预措施
Fosmidomycin-Clindamycin
Single arm study. Co-administration of Fosmidomycin and Clindamycin.
干预措施: Fosmidomycin and Clindamycin co-administration (Drug)
结局指标
主要结局
Day 28 cure rate >95%
时间窗: 28 days
次要结局
- Day 7 cure rate of 100%(Day 6)
- Parasite Clearance Time(0-7 days)
- Fever Clearance Time(0-7 days)