Pharmacokinetics of Glucocorticoids in Children (GLUCOPED)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Children Receiving Prednisone or Prednisolone or Methylprednisolone or Hydrocortisone

Treatments: Biological: Pharmacokinetic

Study type: Observational

Funder types: Other

Identifiers

NCT02252237

2014-A00987-40

Details and patient eligibility

About

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.

Full 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.

Enrollment: 146 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

146 participants in 1 patient group

Children with glucocorticoids

Description:

Children receiving Prednisone or Prednisolone or Methylprednisolone Pharmacokinetic

Treatment:

Biological: Pharmacokinetic