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Optimizing PreTerm Infant Ampicillin Dosing
Sponsor: Duke University
Summary
The goal of this clinical trial is to learn if preterm infants who are prescribed antibiotics shortly after birth can safety 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 a blood sample collected 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
Official title: An Open-label, Pharmacokinetic and Safety Trial Optimizing PreTerm Infant Ampicillin Dosing
Key Details
Gender
All
Age Range
0 Days - 7 Days
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-07
Completion Date
2027-12
Last Updated
2026-05-28
Healthy Volunteers
No
Interventions
Ampicillin prescribed by provider per standard of care for evaluation of early onset sepsis
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
Locations (1)
Duke Health Neonatal Intensive Care Unit
Durham, North Carolina, United States