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Optimizing PreTerm Infant Ampicillin Dosing

RecruitingPhase 1, Phase 2Ages 0 Days - 7 DaysAllDuke University
NCT07610486 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Ampicillin prescribed by provider per standard of care for evaluation of early onset sepsis
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Where

1 site
Duke Health Neonatal Intensive Care Unit
Durham, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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