NCT07610486 Optimizing PreTerm Infant Ampicillin Dosing
| NCT ID | NCT07610486 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Duke University |
| Condition | Early Onset Sepsis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-07-28 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2026-07-28 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07610486 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 7 Days, studying Early Onset Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07610486 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07610486 currently recruiting?
Yes, NCT07610486 is actively recruiting participants. Contact the research team at angelique.boutzoukas@duke.edu for enrollment information.
Where is the NCT07610486 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT07610486 clinical trial?
NCT07610486 is sponsored by Duke University. The trial plans to enroll 60 participants.