RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

Optimizing PreTerm Infant Ampicillin Dosing

Sponsor: Duke University • ClinicalTrials.gov ID: NCT07610486

Registry updated: 2026-10-05

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Description

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

Interventions

Ampicillin prescribed by provider per standard of care for evaluation of early onset sepsis (Drug)
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

Eligibility criteria

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 0/7 to 34 6/7 weeks who have received \> 32 to 36 hours of ampicillin, depending on dosing regimen * Has major congenital abnormalities where survival to 30 days of life is not expected * Receives a course of ampicillin that is longer (i.e., more doses) than the short-course defined regimen for their GA * Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Conditions

Early Onset Sepsis Preterm Neonates NICU Ampicillin Safety and Pharmacokinetics

Locations

Duke Health Neonatal Intensive Care Unit — Durham, North Carolina, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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