Optimizing PreTerm Infant Ampicillin Dosing
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age0-7
SponsorDuke University
About this trial
The goal of this clinical trial is to learn if preterm infants who are prescribed antibiotics shortly after birth can safely 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Documented informed consent from parent/guardian
Infants admitted to the Duke Neonatal Intensive Care Unit (NICU)
less than or equal to 34 6/7 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
Disqualifiers
Infant on extracorporeal support (e.g., ECMO)
Positive blood culture or other confirmed infection
At time of consent, infants with GA <28 0/7 weeks who have received more than 24 hours of empiric ampicillin OR infants with GA 28 0/7 to 34 6/7 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
Trial design
Design model
Single group
Treatments tested in this trial
Ampicillin prescribed by provider per standard of care for evaluation of early onset sepsis
Drugpreterm 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
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Short-course AmpicillinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Total plasma ampicillin concentration
Total 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 total 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.
Time frame
data will be collected up to 50 hours from the first dose of ampicillinSecondary outcomes
1
Serious, unexpected, suspected adverse reactions to ampicillin
Time frame
Data will be collected until 30 days from short-course ampicillin, or until hospital discharge2
Adverse events related to study procedures
Time frame
Data will be collected until 30 days from short-course ampicillin, or until hospital discharge3
All-cause mortality at 30 days
Time frame
Data will be collected until 30 days from short-course ampicillin, or until hospital discharge4
Antibiotic re-initiation within 7 days of short-course ampicillin
Time frame
Data will be collected until 7 days from short-course ampicillinSponsors and contacts
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov