RecruitingPhase 1Phase 2NCT07610486

Optimizing PreTerm Infant Ampicillin Dosing

An Open-label, Pharmacokinetic and Safety Trial Optimizing PreTerm Infant Ampicillin Dosing


Sponsor

Duke University

Enrollment

60 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

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 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


Eligibility

Min Age: 0 DaysMax Age: 7 Days

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Ampicillin prescribed by provider per standard of care for evaluation of early onset sepsis for people with ampicillin, early-onset sepsis, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAmpicillin 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

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NCT07610486


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