Recruiting
Phase 1
Phase 2

Ampicillin

Sponsor:

Duke University

Code:

NCT07610486

Conditions

Early Onset Sepsis

Preterm Neonates

NICU

Ampicillin

Safety and Pharmacokinetics

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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 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

Conditions

Early Onset Sepsis

Preterm Neonates

NICU

Ampicillin

Safety and Pharmacokinetics

Study ID

NCT07610486

Start date

Jul 28, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Angelique Boutzoukas, MD, MPH

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

Locations

Duke Health Neonatal Intensive Care Unit

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Angelique E Boutzoukas, MD, MPH

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

Stefany Olague, MPH

smalltrials-CRC@duke.edu

Principal Investigator:

Angelique E Boutzoukas, MD, MPH

More Information

Sponsor

Duke University

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-08-05.