Population Pharmacokinetics Of Ceftazidime, Ciprofloxacin And Voriconazole In Paediatric Young Patients (< 12 Years Old)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 214
- 试验地点
- 14
- 主要终点
- Population pharmacokinetic parameters and factors explaining variability
研究概览
简要总结
The Pharm A project is a French national collaborative project aiming to determine the population pharmacokinetics of ceftazidime, ciprofloxacin, and voriconazole in paediatric patients aged one month to five years.
详细描述
The licensing process was introduced in order to ensure that medicines are safe, effective and of high quality. However, over 50% of children admitted to hospital in France and Europe will receive an unlicensed or off-label medicine. This occurs for most drugs in children less than 6 years of age. They represent a particularly vulnerable subgroup of the paediatric population.
There are major practical and ethical issues in relation to studying medicines in paediatric patients aged 5 years or less.
- They represent only a small part of the population as compared to older children and adults, and the variation of specific types of diseases in this young subpopulation is higher than in the paediatric counterpart. There are major differences in drug disposition in the different age groups.
- There is a need for suitable methodological approaches for clinical trials
- There are major ethical issues It is essential, therefore, to recruit children from various regions in France in order to obtain a critical sample size of sufficient magnitude and to conduct scientific sound studies. This will be achieved by performing Pharm A, a population pharmacokinetic study of three different anti infectious agents (ceftazidime, ciprofloxacin, voriconazole) and identify covariates including pharmacogenetic biomarkers that explain pharmacokinetic variability.
After parental informed consent, sampling strategy will be randomized depending on the drug and the age group (2 samples in patients below 2 years and 3 samples in patients from 2 to 5 years).
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
- 28 Days 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 28 days to 11 years (< 12 years)
- •Receiving one of the following drugs for therapeutic reasons : ceftazidime, ciprofloxacin, voriconazole
- •Representative for the clinician, a condition requiring the use of these molecules
- •Informed consent signed by the two parents or legal representative
- •Child affiliated to the national social security system
排除标准
- •Not Applicable
研究组 & 干预措施
Patients treated with Ceftazidime
干预措施: Ceftazidime (Drug)
Patients treated with Ciprofloxacin
干预措施: Ciprofloxacin (Drug)
Patients treated with Voriconazole
干预措施: Voriconazole (Drug)
结局指标
主要结局
Population pharmacokinetic parameters and factors explaining variability
时间窗: Between 2 and 4 days after the begining of the treatment
Population Pharmacokinetic Parameters and variability factors (Sex, Age, Genetic factors...) for ceftazidime, ciprofloxacin and voriconazole. According to the age of participants, 2 or 3 bloods sampling will be take between 2 and 4 days after the beginning of the treatment.
次要结局
- Covariability factors explaining the variability (age, biological data, pharmacokinetics factors, associated treatments...)(Between 2 and 4 days after the beginning of the treatment)