Children Receiving Prednisone or Prednisolone or Methylprednisolone or Hydrocortisone
Conditions
Keywords
Prednisone, Prednisolone, Methylprednisolone, Glucocorticoids, pharmacokinetics, hydrocortisone
Brief summary
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
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.
Interventions
BIOLOGICALPharmacokinetic
Blood sample of 2 ml at enrolment and then at following visits. Buccal cell collection swab
Sponsors
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of Pharmacokinetic parameter for Prednisone, Prednisolone, Methylprednisolone, hydrocortisone | 24 months | Assessed by: * Volume of distribution of creatinine * Creatinine clearance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects | 24 months | Ferryman and Gallwey score |
| Analysis of genetic polymorphism of proteins taking part in glucocorticoids metabolism | 24 months | — |
Countries
France
Outcome results
None listed