Optimizing PreTerm Infant Ampicillin Dosing

NCT07610486 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: Pro001198551K23HD113839
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Free plasma ampicillin concentration

  Free plasma ampicillin concentration at 48(+/-) 2 hours after ampicillin initiation, following a single gestational age defined short-course with no further ampicillin administration. Target attainment defined as free ampicillin concentration of ≥1 µg/mL. The short-course regimen is considered successful if target attainment is achieved in ≥90% of the overall study population.

  data will be collected up to 50 hours from the first dose of ampicillin

Secondary Outcomes (6)

• Serious, unexpected, suspected adverse reactions to ampicillin

  Data will be collected until 30 days from short-course ampicillin, or until hospital discharge

• Adverse events related to study procedures

  Data will be collected until 30 days from short-course ampicillin, or until hospital discharge

• All-cause mortality at 30 days

  Data will be collected until 30 days from short-course ampicillin, or until hospital discharge

• Antibiotic re-initiation within 7 days of short-course ampicillin

  Data will be collected until 7 days from short-course ampicillin

• Culture-confirmed bacteremia within 7 days of short-course ampicillin

  Data will be collected until 7 days from short-course ampicillin

Study Arms (1)

Short-course Ampicillin

EXPERIMENTAL

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

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

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

Short-course Ampicillin

Eligibility Criteria

• Age: 0 Days - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Documented informed consent from parent/guardian
• Infants admitted to the Duke Neonatal Intensive Care Unit (NICU)
• less than or equal to 34 completed 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

You may not qualify if:

• Infant on extracorporeal support (e.g., ECMO)
• Positive blood culture or other confirmed infection
• At time of consent, infants with GA \<28 completed weeks who have received more than 24 hours of empiric ampicillin OR infants with GA 28 to 34 completed 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
• Failure to obtain consent from parent/guardian
• 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

Sponsors & Collaborators

• Duke University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Duke Health Neonatal Intensive Care Unit

Durham, North Carolina, 27705, United States

Location

Central Study Contacts

Angelique Boutzoukas, MD, MPH

CONTACT

919-668-4733; angelique.boutzoukas@duke.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 28, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The IPD and supporting information will be available once data analysis is complete and will be available per NICHD DASH repository timelines.
• Access Criteria: Qualified researchers and scientists from academic, non-profit, and for-profit institutions can access data sent to NICHD DASH repository for secondary analysis. Access is controlled, requiring approval from the DASH Data Access Committee (DAC) after the investigator submits a research proposal, a data use agreement (DUA), and a study-specific Data Management and Sharing Plan.

Locations

US (1)