Journal articles
Population pharmacokinetic meta-analysis of individual data to design the first randomized efficacy trial of vancomycin in neonates and young infants
Abstract : Objectives
In the absence of consensus, the present meta-analysis was performed to determine an optimal dosing regimen of vancomycin for neonates.
Methods
A ‘meta-model’ with 4894 concentrations from 1631 neonates was built using NONMEM, and Monte Carlo simulations were performed to design an optimal intermittent infusion, aiming to reach a target AUC0–24 of 400 mg·h/L at steady-state in at least 80% of neonates.
Results
A two-compartment model best fitted the data. Current weight, postmenstrual age (PMA) and serum creatinine were the significant covariates for CL. After model validation, simulations showed that a loading dose (25 mg/kg) and a maintenance dose (15 mg/kg q12h if <35 weeks PMA and 15 mg/kg q8h if ≥35 weeks PMA) achieved the AUC0–24 target earlier than a standard ‘Blue Book’ dosage regimen in >89% of the treated patients.
Conclusions
The results of a population meta-analysis of vancomycin data have been used to develop a new dosing regimen for neonatal use and to assist in the design of the model-based, multinational European trial, NeoVanc.
https://hal-amu.archives-ouvertes.fr/hal-02592795
Contributor : Administrateur Hal Amu <>
Submitted on : Friday, May 15, 2020 - 4:36:36 PM
Last modification on : Friday, December 11, 2020 - 8:21:35 AM
Contributor : Administrateur Hal Amu <>
Submitted on : Friday, May 15, 2020 - 4:36:36 PM
Last modification on : Friday, December 11, 2020 - 8:21:35 AM
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Distributed under a Creative Commons Attribution - NonCommercial - NoDerivatives 4.0 International License
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