Optimizing PreTerm Infant Ampicillin Dosing

Conditions

• Ampicillin
• Early Onset Sepsis
• NICU
• Preterm Neonates
• Safety and Pharmacokinetics

Eligibility Criteria

Sex

ALL

Age

0 Days - 7 Days

Healthy Volunteers

Not accepted

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

Study Details

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

Key Dates

Start date

Jul 31, 2026

Status verified

May 2026

Primary completion

Jul 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

60 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Short-course Ampicillin
  Infants enrolled in the trial receive short-course empiric ampicillin (24 to 36 hours, depending on gestational age and prescribed dosing regimen), rather than a standard (48 hour) empiric ampicillin course

Primary Outcome Measure

Free plasma ampicillin concentration [ Time Frame: data will be collected up to 50 hours from the first dose of ampicillin ]

Central Contacts

• Angelique Boutzoukas, MD, MPH
  919-668-4733
  [email protected]

Locations (1)

Find similar trials in Durham, NC

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