Observational Trial of a 48-Hour Gentamicin Dosing Regimen Derived from Monte Carlo Simulations in Infants Born at Less than 28 Weeks' Gestation - 07/03/14
, Ronnie Guillet, MD, PhD a, Mary Caserta, MD b, Robert DiCenzo, PharmD c
Reprint requests: Erik S. Thingvoll, MD, Department of Pediatrics–Division of Neonatology, University of Rochester Medical Center, 601 Elmwood Ave, Box 651, Rochester, NY 14642Résumé |
Objective |
To develop and validate a 48-hour gentamicin dosing regimen for infants born at <28 weeks' gestation.
Study design |
Using previously published pharmacokinetic data, we performed Monte Carlo simulations for several candidate gentamicin dosing regimens. On the basis of these simulations, we changed dosing for infants born at <28 weeks to 4.5 mg/kg every 48 hours. We then conducted an observational study of 30 infants on this new regimen and compared serum gentamicin levels with 60 historical control subjects who received 2.5 mg/kg every 24 hours.
Results |
Infants in the 48-hour group achieved higher gentamicin peaks (mean 9.43 μg/mL vs 6.0 μg/mL, P < .001) and lower gentamicin troughs (mean 1.08 μg/mL vs 1.54 μg/mL, P < .001) compared with the 24-hour group. Seven percent of the 48-hour group infants had a gentamicin peak <6 μg/mL versus 43% in the 24-hour group. With a goal for peaks of 6 to 12 μg/mL and for troughs of <1.5 μg/mL, infants in the 48-hour group required fewer adjustments of their dosing regimens compared with the 24-hour group (26.7% vs 78.3%).
Conclusions |
Gentamicin given every 48 hours to infants born at <28 weeks achieves optimal blood concentrations more frequently than does once-daily dosing. Monte Carlo simulations on the basis of pharmacokinetic modeling are useful to optimize drug dosing in premature infants.
Le texte complet de cet article est disponible en PDF.Abbreviations : MIC, OAE
Plan
| Supported by grant number T32AI007464 from the National Institutes of Health. The authors declare no potential, real, or perceived conflicts of interest. |
Vol 153 - N° 4
P. 530-534 - octobre 2008 Retour au numéro
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