Pharmacokinetics of Glucocorticoids in Children (GLUCOPED)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study of Pharmacokinetic Variability of Glucocorticoids in Children

Conditions
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Children Receiving Prednisone or Prednisolone or Methylprednisolone or Hydrocortisone

Intervention / Treatment
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* Biological: Pharmacokinetic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: parental refusal inability to take a blood sample inhaled corticoids intake in the 3 previous days topical corticoids intake in the 3 previous days
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with glucocorticoids<br>Children receiving Prednisone or Prednisolone or Methylprednisolone Pharmacokinetic | Biological: Pharmacokinetic<br>* Blood sample of 2 ml at enrolment and then at following visits. Buccal cell collection swab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of Pharmacokinetic parameter for Prednisone, Prednisolone, Methylprednisolone, hydrocortisone | Assessed by: Volume of distribution of creatinine Creatinine clearance | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects | Ferryman and Gallwey score | 24 months | 
| Side effects | Dermaphot® score | 24 months | 
| Analysis of genetic polymorphism of proteins taking part in glucocorticoids metabolism |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prednisone, Prednisolone, Methylprednisolone, Glucocorticoids, pharmacokinetics, hydrocortisone