A Multicenter, Open Label, Efficacy and Safety Study of Parenteral SAR97276A in the Treatment of Symptomatic Uncomplicated and Severe Malaria in Adults and Children
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Combination of fever clearance, general condition improvement at 48h parasite reduction at 72h and no need for rescue therapy at 72h
研究概览
简要总结
The objective of the study is to assess the efficacy and safety of SAR97276A in severe malaria in pediatric patients. Before treating pediatric patients with severe malaria, the efficacy and safety of SAR97276A will be first tested in adult patients, then in pediatric patients, with uncomplicated malaria.
The safety and the concentration of SAR97276A in blood and plasma will be assessed in adult and pediatric patients.
详细描述
The treatment will be administered by intramuscular or intravenous route depending on the cohort. The treatment will be administered as single dose or 3-day repeated dose. The patients will be hospitalized for 3 days and followed up to 28 days following study treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with uncomplicated malaria will be enrolled in cohort 1
- •Pediatric patients with uncomplicated malaria will be enrolled in cohort 2
- •Pediatric patients with severe malaria will be enrolled in cohort 3
- •Plasmodium falciparum malaria confirmed in blood smear
- •Fever within the last 24 hours.
排除标准
- •Treatment with an antimalarial agent within 72h of screening
- •Severe concomitant disease
- •Pregnant or breast-feeding women
- •Women of child bearing potential not protected by an effective method of birth control
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Cohort 1
Adult patients with uncomplicated malaria
干预措施: SAR97276A (Drug)
Cohort 2
Pediatric patients with uncomplicated malaria
干预措施: SAR97276A (Drug)
Cohort 3
Pediatric patients with severe malaria
干预措施: SAR97276A (Drug)
结局指标
主要结局
Combination of fever clearance, general condition improvement at 48h parasite reduction at 72h and no need for rescue therapy at 72h
时间窗: 3 initial days
次要结局
- Parasite reduction(3 initial days (72h))
- Safety assessment(28 days post 1st study drug administration)