Clinical Trial

Optimizing PreTerm Infant Ampicillin Dosing

Study acronym: OPTI-Amp
Recruiting Phase 1/2
View on ClinicalTrials.gov →
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
Protocol Amendment History 3 changes
minor Completion pushed: 2027-12 -> 2027-12-31 2026-08-06
critical Recruitment opened 2026-07-30
critical Primary endpoint(s) modified 2026-07-30
Trial Details
NCT Number NCT07610486
Lead Sponsor Duke University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Early Onset Sepsis, Preterm Neonates, NICU, Ampicillin, Safety and Pharmacokinetics
Enrollment 60 participants
Start Date 2026-07-28
Primary Completion 2027-07-01 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-05