Study Results
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Basic Information
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COMPLETED
NA
57 participants
INTERVENTIONAL
2019-02-13
2020-12-12
Brief Summary
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* study the pharmacokinetic parameters (Pop PK) of Amiodarone in children;
* identify covariates explaining the variability of these pharmacokinetic parameters;
* study the relationship between the concentration, the efficacy of treatment and its tolerance to optimize the use of Amiodarone in pediatrics.
Indeed, there is no consensus on the optimal oral dosage in children. Few pharmacokinetic studies have been performed with only a small number of patients per study. Our study will include 70 children aged 0 to 18 years old.
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Detailed Description
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The efficacy of oral amiodarone in children has been shown in studies in 1980; however, there is no consensus on optimal dosage. Despite its widespread use in children, few pharmacokinetic studies have been conducted in a small number of patients at different doses. The population pharmacokinetics and pharmacodynamics of Amiodarone in children, as well as its general and scientific interest, will be studied in this study. The lack of efficacy and the occurrence of adverse events of Amiodarone in children may be related to the large inter-individual pharmacokinetic variability.
Currently, more than 200 children treated with Amiodarone are being followed at Necker-Enfants malades Hospital.
This prospective study will be conducted in three paediatric services of Necker-Enfants malades Hospital in Paris, France.
Patient selection will take place in the 3 paediatric services. The senior physician proposes the study to holders of parental authority whose child receives or will receive the treatment during its follow-up or hospitalization.
After verification of the inclusion and exclusion criteria, the consent of the parents or parental authority and the child, according to his age, will be obtained.
After agreement, and/or signature of the parents and the non-oral opposition of the child in age to understand the information, the child is sampled according to the following scheme:
* The samples taken during the introduction of the treatment in hospital will be made to observe the pharmacokinetics at the first dose: 3 samples will be taken in the following time windows: \[H0-H3\]; \[H5-H9\] and just before the next dose administration (H24).
* During the maintenance treatment, a sample will be taken during a scheduled consultation or during a hospitalization.
* Blood PK samples will be drawn until 1 month after end of treatment.
All patients' samples will be kept for to be analyzed at the Pharmacology department of the Cochin hospital.
No intervention or no charge will be made for this study.
This population pharmacokinetic study in children aims to analyze the concentration-effectiveness and concentration-tolerance relationship to optimize its use.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Amiodarone dosage
Blood pharmacokinetics samples
Blood pharmacokinetic samples
1 or 3 sample(s) will be taken in the following time windows: \[H0-H3\]; \[H5-H9\] and just before the next set \[H24\], depending if the child is or is not admitted to hospital
Interventions
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Blood pharmacokinetic samples
1 or 3 sample(s) will be taken in the following time windows: \[H0-H3\]; \[H5-H9\] and just before the next set \[H24\], depending if the child is or is not admitted to hospital
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Known liver dysfunction
18 Years
ALL
No
Sponsors
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URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Jean-Marc TRELUYER, MD, PhD
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Damien BONNET, MD, PhD
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Sylvain RENOLLEAU, MD, PhD
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Amelia LEHNERT, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Necker Hospital
Paris, , France
Countries
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References
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Lehnert A, Foissac F, Bouazza N, Urien S, Oualha M, Renolleau S, Barbanti C, Di Marzio A, Bonnet D, Abdalla S, Zheng Y, Treluyer JM. Amiodarone/N-desethylamiodarone population pharmacokinetics in paediatric patients. Br J Clin Pharmacol. 2022 Dec;88(12):5369-5377. doi: 10.1111/bcp.15458. Epub 2022 Jul 29.
Dallefeld SH, Atz AM, Yogev R, Sullivan JE, Al-Uzri A, Mendley SR, Laughon M, Hornik CP, Melloni C, Harper B, Lewandowski A, Mitchell J, Wu H, Green TP, Cohen-Wolkowiez M. A pharmacokinetic model for amiodarone in infants developed from an opportunistic sampling trial and published literature data. J Pharmacokinet Pharmacodyn. 2018 Jun;45(3):419-430. doi: 10.1007/s10928-018-9576-y. Epub 2018 Feb 12.
Garson A Jr, Gillette PC, McVey P, Hesslein PS, Porter CJ, Angell LK, Kaldis LC, Hittner HM. Amiodarone treatment of critical arrhythmias in children and young adults. J Am Coll Cardiol. 1984 Oct;4(4):749-55. doi: 10.1016/s0735-1097(84)80402-7.
Coumel P, Fidelle J. Amiodarone in the treatment of cardiac arrhythmias in children: one hundred thirty-five cases. Am Heart J. 1980 Dec;100(6 Pt 2):1063-9. doi: 10.1016/0002-8703(80)90214-8.
Bucknall CA, Keeton BR, Curry PV, Tynan MJ, Sutherland GR, Holt DW. Intravenous and oral amiodarone for arrhythmias in children. Br Heart J. 1986 Sep;56(3):278-84. doi: 10.1136/hrt.56.3.278.
Pollak PT, Bouillon T, Shafer SL. Population pharmacokinetics of long-term oral amiodarone therapy. Clin Pharmacol Ther. 2000 Jun;67(6):642-52. doi: 10.1067/mcp.2000.107047.
Other Identifiers
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2018-A02327-48
Identifier Type: REGISTRY
Identifier Source: secondary_id
APHP180299
Identifier Type: -
Identifier Source: org_study_id
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