AP-HP Necker
Paris, 75015, France
Completed
NCT Number: NCT02252237
Pharmacokinetics of Glucocorticoids in Children (GLUCOPED)
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.
Completed
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Notify MeKey information
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Pharmacokinetic
BiologicalBlood sample of 2 ml at enrolment and then at following visits. Buccal cell collection swab
Primary outcomes
-
Composite of Pharmacokinetic parameter for Prednisone, Prednisolone, Methylprednisolone, hydrocortisone
Time frame: 24 months
Assessed by:
- Volume of distribution of creatinine
- Creatinine clearance
Secondary outcomes
-
Side effects
Time frame: 24 months
Ferryman and Gallwey score
-
Side effects
Time frame: 24 months
Dermaphot® score
-
Analysis of genetic polymorphism of proteins taking part in glucocorticoids metabolism
Time frame: 24 months
Sponsors and collaborators
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Other
Collaborators
- URC-CIC Paris Descartes Necker Cochin
Registry information
Official study title
Study of Pharmacokinetic Variability of Glucocorticoids in Children
Acronym: GLUCOPED
Important dates
- Study start
- 2014
- Primary completion
- 2021
- Study completion
- 2021
- First posted
- Sep 30, 2014
- Registry last updated
- Nov 20, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.