Pharmacokinetics of Glucocorticoids in Children (GLUCOPED) (GLUCOPED)

November 14, 2023 updated by: Assistance Publique - Hôpitaux de Paris

Study of Pharmacokinetic Variability of Glucocorticoids in Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

146

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • AP-HP Necker

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children with glucocorticoids
Children receiving Prednisone or Prednisolone or Methylprednisolone Pharmacokinetic
Biological: Pharmacokinetic
Blood sample of 2 ml at enrolment and then at following visits. Buccal cell collection swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of Pharmacokinetic parameter for Prednisone, Prednisolone, Methylprednisolone, hydrocortisone
Time Frame: 24 months

Assessed by:

  • Volume of distribution of creatinine
  • Creatinine clearance
24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Director: Jean-Marc Tréluyer, MD-PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2014

Primary Completion (Actual)

December 9, 2021

Study Completion (Actual)

December 9, 2021

Study Registration Dates

First Submitted

September 26, 2014

First Submitted That Met QC Criteria

September 29, 2014

First Posted (Estimated)

September 30, 2014

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014-A00987-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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