Optimizing Meropenem Therapy for Severe Nosocomial Infections in Neonates
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Meropenem pharmacokinetics in neonates exhibits large interindividual variability due to developmental changes occurring during the first month of life. The objective was to characterize meropenem pharmacokinetics through a population approach to determine effective dosing recommendations in neonates with severe nosocomial infections. Three blood samples from forty neonates were obtained once steady-state blood levels were achieved and plasma concentrations were determined with a validated chromatographic method. Data were used to develop and validate the one-compartment with first-order elimination population pharmacokinetic model obtained by non-linear mixed effect modeling. The final model was Clearance (L/h) = 2.23 × Creatinine Clearance (L/h) and Volume of distribution(L) = 6.06 × Body Surface Area(m2) × (1 %2b 0.60 if Fluticasone comedication). Doses should be adjusted based on said covariates to increase the likelihood of achieving therapeutic targets. This model explains 12.9%25 of the interindividual variability for meropenem clearance and 19.1%25 for volume of distribution. Stochastic simulations to establish initial dosing regimens to maximize the time above the MIC showed that the mean probabilities to achieve the PK/PD target (PTA) for microorganisms with a MIC of 2 and 8 µg/mL were 0.8 and 0.7 following i.v. bolus of 250 and 500 mg/m2/dose q8h, respectively. Meropenem extended 4h infusion would improve PTA in neonates with augmented creatinine clearance. © 2021 American Pharmacists Association
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Antiinfectives; Individualized drug therapy; Population pharmacokinetics; Special populations creatinine; fluticasone; meropenem; antiinfective agent; meropenem; Article; body surface; clinical article; controlled study; creatinine clearance; dose response; dose time effect relation; drug blood level; drug clearance; drug infusion; drug targeting; female; high performance liquid chromatography; hospital infection; human; male; minimum inhibitory concentration; newborn; personalized medicine; pharmacodynamics; pharmacokinetic parameters; population research; prospective study; randomized controlled trial; steady state; stochastic model; volume of distribution; cross infection; microbial sensitivity test; Monte Carlo method; Anti-Bacterial Agents; Cross Infection; Humans; Infant, Newborn; Meropenem; Microbial Sensitivity Tests; Monte Carlo Method
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