The Ampicillin in Infants Study

Evaluating the safety and pharmacokinetics of the commonly used antibiotic ampicillin in infants by reviewing previously collected clinical data.

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).



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

Principal Investigators:
Adriana Tremoulet, MD
UC San Diego, CA

Michael Cohen-Wolkowiez, MD, PhD
Duke Health, Durham, NC