The goal of this study was to evaluate the pharmacokinetics and safety of ampicillin for the treatment of sepsis and/or meningitis in infants at various gestational ages, chronological ages, and birth weights.
Ampicillin is the most commonly prescribed medication in the neonatal intensive care unit (NICU), used for treatment of bacterial infections including sepsis and meningitis. However, information was lacking on dosing and safety in the infant population.
We examined prospectively collected data from infants admitted between 1997 and 2010 at 305 intensive care nurseries managed by the Pediatrix Medical Group in the United States. A pharmacokinetic data analysis was performed, in combination with a retrospective chart review of collected information, to verify clinical data. We examined all recorded laboratory values and diagnoses associated with ampicillin use in infants with and without culture-proven infections. We also compared the odds of adverse events in infants receiving ampicillin alone or in combination with other antibiotics (e.g., cefotaxime, vancomycin, gentamicin). View study data for ampicillin PK/safety in infants on NICHD's Data and Specimen Hub (DASH).
- Comparative Analysis of Ampicillin Plasma and Dried Blood Spot Pharmacokinetics in Neonates Therapeutic Drug Monitoring • February 2018. Le J, Poindexter B, Sullivan JE, Laughon M, Delmore P, Blackford M, Yogev R, James LP, Melloni C, Harper B, Mitchell J, Benjamin DK Jr, Boakye-Agyeman F, Cohen-Wolkowiez M. Dried blood spot (DBS) is a practical sampling strategy for pharmacokinetic studies in neonates. The utility of DBS to determine the population ...
- Electronic Health Records and Pharmacokinetic Modeling to Assess the Relationship between Ampicillin Exposure and Seizure Risk in Neonates Journal of Pediatrics • August 2016. Hornik CP, Benjamin DK Jr, Smith PB, Pencina MJ, Tremoulet AH, Capparelli EV, Ericson JE, Clark RH, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act—Pediatric Trials Network. This was a retrospective observational cohort study of electronic health record (EHR) data combined with pharmacokinetic model derived drug exposure predictions. We used the EHR ...
- Characterization of the population pharmacokinetics of ampicillin in neonates using an opportunistic study design Antimicrobial Agents and Chemotherapy • June 2014. Tremoulet A, Le J, Poindexter B, Sullivan JE, Laughon M, Delmore P, Salgado A, Ian-U Chong S, Melloni C, Gao J, Benjamin DK Jr, Capparelli EV, Cohen-Wolkowiez M; Administrative Core Committee of the Best Pharmaceuticals for Children Act-Pediatric Trials Network. Although ampicillin is the most commonly used drug in neonates, ...
Pediatric Academic Societies Annual Meeting, May 3-6, 2014
Dose-Safety Relationship for Acyclovir in the Treatment of Neonatal Herpes Simplex Virus
Hornik CP, Benjamin DK Jr., Clark RH, Capparelli EV, Le J, Tremoulet A, Cohen-Wolkowiez M, Smith PB, for the Best Pharmaceuticals for Children Act–Pediatric Trials Network
Pediatric Academic Societies Annual Meeting, May 4-7, 2013
Ampicillin Safety in Hospitalized Infants
Hornik CP, Van Ginkel MW, Benjamin Jr, DK, Cohen-Wolkowiez M, Smith PB
Completed; clinical study report submitted to FDA
NICHD Data and Specimen Hub (DASH):
Ampicillin - PK/Safety in Infants
Adriana Tremoulet, MD
UC San Diego, CA
Michael Cohen-Wolkowiez, MD, PhD
Duke Health, Durham, NC