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NCT07610486 · ClinicalTrials.gov registry record · Phase 1
Optimizing PreTerm Infant Ampicillin Dosing
A Phase 1 study, sponsored by Duke University.
- Not yet
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT07610486: Clinical Trial Phase 1 study, sponsored by Duke University.
NCT07610486 is a Phase 1 study that has not yet begun recruiting, run by Duke University. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07610486, a Phase 1 study, has not yet begun recruiting, sponsored by Duke University.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
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
Primary Outcome
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.
Interventions
- DRUG Ampicillin prescribed by provider per standard of care for evaluation of early onset sepsis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-07 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What is known before NCT07610486 opens enrollment
NCT07610486 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Ampicillin prescribed by provider per standard of care for evaluation of early onset sepsis is the first listed.
NCT07610486 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07610486 about?
NCT07610486 is a clinical study titled "Optimizing PreTerm Infant Ampicillin Dosing". 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 lev...
What is the current status of trial NCT07610486?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2026-07. Estimated completion is 2027-12.
What interventions are being tested in trial NCT07610486?
The interventions under investigation include: Ampicillin prescribed by provider per standard of care for evaluation of early onset sepsis (DRUG).
Who is sponsoring clinical trial NCT07610486?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07610486's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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