Study of Pharmacokinetic Variability of Glucocorticoids in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Composite of Pharmacokinetic parameter for Prednisone, Prednisolone, Methylprednisolone, hydrocortisone
研究概览
简要总结
The purpose of this study is to determine individual susceptibility factors (drug interactions, genetic factors such as enzyme polymorphism…) to explain wide interindividual variability towards corticosteroids (prednisone, prednisolone, methylprednisolone, hydrocortisone) in children, which could establish a base for therapeutic monitoring.
详细描述
Corticosteroids are widely used in children. A large interindividual variability exists concerning both efficacity and tolerance. Pharmacokinetic is poorly known.
A knowledge of individual susceptibility factors would allow to better adapt therapy in each case.
Drugs evaluated here are used in routine care in children and will be prescribed according to department practices concerning treated disease. Medical checks will be done during usual follow-up. Several features will be collected: reason of treatment, drug chosen and prescription modalities, observance, concomitant treatments, side effects, clinical examination, photography, score… Blood samples will be performed at different interval during usual biological follow-up. Three samples per patient will be required for pharmacokinetic and pharmacogenetic.
170 children under prednisone/prednisolone,130 under methylprednisolone, and 100 children under hydrocortisone will be recruited in four pediatric medical departments: immuno-hematology, nephrology,dermatology, and pediatric neurology.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •receiving Prednisone or Prednisolone or Methylprednisolone or hydrocortisone
- •recruited in Immuno-hematological unit, dermatological unit, in pediatric nephrological unit, pediatric intensive care unit, or pediatric neurology unit
- •parental agreement
排除标准
- •parental refusal
- •inability to take a blood sample
- •inhaled corticoids intake in the 3 previous days
- •topical corticoids intake in the 3 previous days
研究组 & 干预措施
Children with glucocorticoids
Children receiving Prednisone or Prednisolone or Methylprednisolone Pharmacokinetic
干预措施: Pharmacokinetic (Biological)
结局指标
主要结局
Composite of Pharmacokinetic parameter for Prednisone, Prednisolone, Methylprednisolone, hydrocortisone
时间窗: 24 months
Assessed by: * Volume of distribution of creatinine * Creatinine clearance
次要结局
- Analysis of genetic polymorphism of proteins taking part in glucocorticoids metabolism(24 months)
- Side effects(24 months)