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 is 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.

Adriana Tremoulet, MD, of Rady Children's Hospital, discusses the ampicillin study.

Summary

Ampicillin is the most commonly prescribed medication in the intensive care nursery, with an exposure rate of 693 per 1000 discharges, for treatment of bacterial infections including sepsis and meningitis. However, data on dosing and safety in the infant population are incomplete.

We will examine 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 will be performed in combination with retrospective chart review of collected information to verify clinical data. We will examine all recorded laboratory values and diagnoses associated with ampicillin use in infants with and without culture-proven infections. We will also compare the odds of adverse events in infants receiving ampicillin alone or in combination with other antibiotics (e.g., cefotaxime, vancomycin, gentamicin).

Publications

Characterization of the population pharmacokinetics of ampicillin in neonates using an opportunistic study design.
Tremoulet A, Le J, Poindexter B, Sullivan JE, Laughon M, Delmore P, Salgado A, Chong SI, Melloni C, Gao J, Benjamin DK Jr, Capparelli EV, Cohen-Wolkowiez M; on behalf of the Administrative Core Committee of the Best Pharmaceuticals for Children Act — Pediatric Trials Network.
Antimicrobial Agents and Chemotherapy • June 2014, volume 58, issue 6, pages 3013-3020.
PMCID: PMC3904301 [Free PMC article]

Presentations

Pediatric Academic Societies Annual Meeting, May 3-6, 2014

Ampicillin Exposure and Odds of Seizures in a Large Cohort of Hospitalized Neonates
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

OVERVIEW

Status:
Published; clinical study report submitted to FDA

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

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

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