Clinical trial NCT02252237: Pharmacokinetics of Glucocorticoids in Children (GLUCOPED)
Official title: Study of Pharmacokinetic Variability of Glucocorticoids in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children Receiving Prednisone or Prednisolone or Methylprednisolone or Hydrocortisone
Keywords: Prednisone
Prednisolone
Methylprednisolone
Glucocorticoids
pharmacokinetics
hydrocortisone
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-09-30
Enrollment: 146
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children receiving glucocorticoids (Prednisone or Prednisolone or Methylprednisolone or hydrocortisone) are recruited in Immuno-hematological unit, dermatological unit, in pediatric nephrological unit, pediatric intensive care unit, or pediatric neurology unit

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite of Pharmacokinetic parameter for Prednisone, Prednisolone, Methylprednisolone, hydrocortisone
timeFrame: 24 months
Secondary outcomes:
measure: Side effects
timeFrame: 24 months
measure: Side effects
timeFrame: 24 months
measure: Analysis of genetic polymorphism of proteins taking part in glucocorticoids metabolism
timeFrame: 24 months
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP Necker
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-Marc Tréluyer, MD-PhD
role: STUDY_DIRECTOR
References:
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citation: Miller PF, Bowmer CJ, Wheeldon J, Brocklebank JT. Pharmacokinetics of prednisolone in children with nephrosis. Arch Dis Child. 1990 Feb;65(2):196-200. doi: 10.1136/adc.65.2.196.
citation: Petersen KB, Jusko WJ, Rasmussen M, Schmiegelow K. Population pharmacokinetics of prednisolone in children with acute lymphoblastic leukemia. Cancer Chemother Pharmacol. 2003 Jun;51(6):465-73. doi: 10.1007/s00280-003-0602-3. Epub 2003 Apr 16.
citation: Faure C, Andre J, Pelatan C, Munck A, Giraud M, Cezard JP, Jacqz-Aigrain E. Pharmacokinetics of intravenous methylprednisolone and oral prednisone in paediatric patients with inflammatory bowel disease during the acute phase and in remission. Eur J Clin Pharmacol. 1998 Sep;54(7):555-60. doi: 10.1007/s002280050512.
citation: de Truchis C, Bouazza N, Foissac F, Charbit M, Dehoux L, Lui G, Ribot M, Briand N, Zheng Y, Treluyer JM, Boyer O. Prednisolone pharmacokinetics after oral prednisone administration in paediatric patients with kidney transplant. Br J Clin Pharmacol. 2023 May;89(5):1532-1540. doi: 10.1111/bcp.15610. Epub 2022 Dec 12.