An Open-label, Randomized Multicenter Study to Investigate the Anti-parasitic Activity, Pharmacokinetic and Safety of IM SAR97276A With Oral ACTs as Positive Control in Children Presenting With Symptomatic Plasmodium Falciparum Uncomplicated Malaria
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Parasite Reduction Ratio (PRR)
研究概览
简要总结
Primary Objective:
To assess the antiparasitic activity of intramuscular (IM) SAR97276A based on parasite reduction ratio at 72 hours in pediatric patients with uncomplicated malaria
Secondary Objectives:
- To assess the evolution of clinical signs and symptoms (including the need for a rescue therapy) in pediatric patients with uncomplicated malaria receiving SAR97276A with reference to Artemisinin-Based Combination Therapy (ACTs)
- To assess the pharmacokinetics profile of SAR97276A in pediatric patients with uncomplicated malaria
- To assess the safety profile of SAR97276A in pediatric patients with uncomplicated malaria
- To assess the pharmacokinetic-pharmacodynamic relationship of SAR97276A
详细描述
The total duration per patients will last approximately 28 ± 2 days broken down as follows:
- A screening phase up to 12-hours
- A 28 ± 2 days study period
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
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Step 1 (SAR97276A od)
1 group of paediatric patients will receive 0.5 mg/kg SAR97276A administration once daily (od) for 3 days
干预措施: SAR97276A (Drug)
Step 1 (SAR97276A bid)
1 group of paediatric patients will receive 0.25 mg/kg SAR97276A administration twice daily (bid) for 3 days
干预措施: SAR97276A (Drug)
Step 1 (ACTs)
1 group of paediatric patients will receive arthemeter + lumefantrine (ACTs) bid for 3 days
干预措施: arthemeter + lumefantrine (ACTs) (Drug)
Step 2 (SAR97276A)
1 or 2 groups of paediatric patients will receive SAR97276A once daily (od) or twice a day (bid) administration for 3 days (the choice of the od or bid regimen will be based on the results obtained in step 1)
干预措施: SAR97276A (Drug)
Step 2 (ACTs)
1 group of paediatric patients will receive arthemeter + lumefantrine (ACTs) bid for 3 days
干预措施: arthemeter + lumefantrine (ACTs) (Drug)
Step 3 (SAR97276A)
1 group of paediatric patients (2 to 11 years old) will receive: SAR97276A od or bid administration for 3 days (depending on results of step 1)
干预措施: SAR97276A (Drug)
结局指标
主要结局
Parasite Reduction Ratio (PRR)
时间窗: at 72 hours
次要结局
- General conditions improvement: mean total symptom score over time(every 6 hours from baseline up to 72 hours (day 4))
- SAR97276 pharmacokinetic profile in plasma and blood(from baseline up to 12 hours after the last study drug intake on (Day 3)
- Evolution of mean Parasitaemia over time (nb/µL)(every 6 hours from baseline up to 72 hours (day 4))
- Fever Clearance (time to reach Temperature < 38°C)(every 6 hours from baseline up to 72 hours (day 4))
- Evolution of mean Gametocytes count over time (nb/µL)(from baseline to end of study (day 28 ± 2))