Duke University
The goal of this clinical trial is to learn if preterm infants who are prescribed antibiotics shortly after birth can safely receive a shorter course of antibiotics (24 to 36 hours instead of 48 hours). The main questions it aims to answer are: * Does short-course ampicillin provide high enough levels of ampicillin at 48 hours? * Is short-course ampicillin safe for preterm infants to receive? Preterm infants who are being prescribed ampicillin by their doctor and enroll in the study will stop ampicillin after a shorter than typical course, and researchers will collect blood samples to measure their ampicillin levels and follow them clinically to see how they do after receiving short-course ampicillin. Participants will: * stop ampicillin earlier than 48 hours (between 24 to 36 hours, depending on how premature they are and the dosing of ampicillin their doctor has prescribed) * have one or more blood samples collected, including one around 48 hours from when they started ampicillin * have their data collected until 30 days after they receive short-course ampicillin, or until hospital discharge, whichever is sooner
OPTI-Amp is a prospective, open-label, non-randomized pharmacokinetic and safety trial of short-course ampicillin administered to preterm neonates in the Neonatal Intensive Care Unit (NICU) at Duke. The objectives of the study are to 1) evaluate whether short-course ampicillin provides therapeutic exposures for 48 hours from ampicillin initiation for preterm neonates undergoing evaluation of early onset sepsis (EOS) and 2) evaluate the safety of short-course ampicillin compared to standard empiric ampicillin. Approximately 60 neonates ≤34 weeks 6/7 days gestational age and \<7 days postnatal…
Inclusion Criteria: * Documented informed consent from parent/guardian * Infants admitted to the Duke Neonatal Intensive Care Unit (NICU) * less than or equal to 34 6/7 weeks gestational age (GA) at birth and \< 7 days of life at time of screening * Prescribed ampicillin by provider per standard of care for evaluation of early onset sepsis Exclusion Criteria: * Infant on extracorporeal support (e.g., ECMO) * Positive blood culture or other confirmed infection * At time of consent, infants with GA \<28 0/7 weeks who have received more than 24 hours of empiric ampicillin OR infants with GA 28…
preterm infants receive less than 48 hours of prescribed ampicillin (i.e., a "short-course" ampicillin regimen) to provide the desired 48 hours of therapeutic exposures