NCT07610486 · Duke University
Optimizing PreTerm Infant Ampicillin Dosing
(OPTI-Amp)
What this study is about
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).
View original scientific description
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.
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
Primary outcome measures
Total plasma ampicillin concentration
Time frame: data will be collected up to 50 hours from the first dose of ampicillin
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Durham, North Carolina
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 5, 2026 · Source of record for eligibility and locations