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Optimizing PreTerm Infant Ampicillin Dosing

NCT07610486 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-28

No results posted yet for this study

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
  • Preterm Neonates
  • NICU
  • Ampicillin
  • Safety and Pharmacokinetics

Interventions

DRUG

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

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

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Duke University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Days
Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-07-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07610486 on ClinicalTrials.gov