Anti-parasitic Activity and Safety Assessment of SAR97276A in Children With Uncomplicated Malaria
2012年12月12日 更新者：Sanofi
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
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
研究概览
详细说明
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
研究类型
介入性
注册 (实际的)
20
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
2年 至 17年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion criteria:
- Patients diagnosed with symptomatic infection by Plasmodium falciparum microscopically confirmed in blood smear at Day-1 visit
- Fever (tympanic or rectal temperature ≥ 38 C) or documented history of fever within the last 24h
- Asexual parasitemia of ≥ 2 000 parasites/μL in blood smear at D-1 visit
- Signed Informed Consent Form by the parents or legal guardian
- Age: 12 to 17 years old for step 1
- Age: 2 to 11 years old for step 2 and step 3
Exclusion criteria:
- Participation in another clinical trial within the last 3 months or participation within a different cohort in this PDY11737 clinical trial or participation to previous trial with SAR97276
- Documented history of adequate treatment with antimalarials expected to be effective within the preceding 72 hours
- Severe concomitant disease (including concomitant febrile illnesses or infection)
- Any sign suggestive of severe malaria
- Severe malnutrition
- Asexual parasitemia: Plasmodium falciparum > 100,000 parasites/μL in blood smear at D-1 visit
- Previous treatment within 3 weeks prior to inclusion, and concomitant treatment with potent CYP3A4 inhibitors or CYP3A4 inducers or CYP2D6 substrates or potent CYP2D6 inhibitors
- Known serious adverse event reaction or hypersensitivity to Artemisinin-Based Combination Therapy (ACTs) or any contraindications from the positive control therapy (Artemisinin Combined Treatments) or warning/precaution of use as defined in the respective National Product Labeling
- Pregnant or breast-feeding women
- Women of childbearing potential not protected by effective contraceptive method of birth control, or not willing to use an effective contraceptive(s) method(s) for the duration of the study (e.g.: double barrier method), and/or who are unwilling or unable to be tested for pregnancy,
- CPK above 3 ULN,
- Underlying hepatobiliary disease or ALT>3 ULN.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Step 1 (SAR97276A od)
1 group of paediatric patients will receive 0.5 mg/kg SAR97276A administration once daily (od) for 3 days
|
Pharmaceutical form:solution for injection Route of administration: intramuscular |
|
实验性的：Step 1 (SAR97276A bid)
1 group of paediatric patients will receive 0.25 mg/kg SAR97276A administration twice daily (bid) for 3 days
|
Pharmaceutical form:solution for injection Route of administration: intramuscular |
|
有源比较器：Step 1 (ACTs)
1 group of paediatric patients will receive arthemeter + lumefantrine (ACTs) bid for 3 days
|
Pharmaceutical form:tablet Route of administration: oral |
|
实验性的：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)
|
Pharmaceutical form:solution for injection Route of administration: intramuscular |
|
有源比较器：Step 2 (ACTs)
1 group of paediatric patients will receive arthemeter + lumefantrine (ACTs) bid for 3 days
|
Pharmaceutical form:tablet Route of administration: oral |
|
实验性的：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)
|
Pharmaceutical form:solution for injection Route of administration: intramuscular |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Parasite Reduction Ratio (PRR)
大体时间：at 72 hours
|
at 72 hours
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Evolution of mean Parasitaemia over time (nb/µL)
大体时间：every 6 hours from baseline up to 72 hours (day 4)
|
every 6 hours from baseline up to 72 hours (day 4)
|
|
Evolution of mean Gametocytes count over time (nb/µL)
大体时间：from baseline to end of study (day 28 ± 2)
|
from baseline to end of study (day 28 ± 2)
|
|
Fever Clearance (time to reach Temperature < 38°C)
大体时间：every 6 hours from baseline up to 72 hours (day 4)
|
every 6 hours from baseline up to 72 hours (day 4)
|
|
General conditions improvement: mean total symptom score over time
大体时间：every 6 hours from baseline up to 72 hours (day 4)
|
every 6 hours from baseline up to 72 hours (day 4)
|
|
SAR97276 pharmacokinetic profile in plasma and blood
大体时间：from baseline up to 12 hours after the last study drug intake on (Day 3
|
from baseline up to 12 hours after the last study drug intake on (Day 3
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年10月1日
初级完成 (实际的)
2012年1月1日
研究完成 (实际的)
2012年1月1日
研究注册日期
首次提交
2011年9月26日
首先提交符合 QC 标准的
2011年9月30日
首次发布 (估计)
2011年10月4日
研究记录更新
最后更新发布 (估计)
2012年12月13日
上次提交的符合 QC 标准的更新
2012年12月12日
最后验证
2012年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.