This prospective study enrolls 60 neonates admitted to the NICU for suspected or proven sepsis in critical state during the first week of life. Four plasma concentrations after the first 30-min infusion (4mg/kg i.v.) were detected by a fluorescence polarization immunoassay (TDx, Abbott Laboratories, IL, USA).
Using MWPharm 3.15. and two-compartment analysis, individual PK parameters were estimated and simulation of Ge concentrations starting from the interval after the second dose was developed.The goal was to individualize the dosing regimen in order to achieve the target ranges related to the 4th dose : Ctrough,3 (0.5-2mg/L) and Cpeak,4 (6-10mg/L). Predicted and assayed values were compared.
Cpeak,4 did not reach the target range in 50% of subjects. The value of Ctrough,3>2mg/l was detected in 2 subjects.
This outcome was ascribed to covariates of both maturational and pathophysiological origin that might significantly influence the pharmacokinetics of Ge.