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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 is a Phase 1 study that has not yet begun recruiting, run by Duke University. The registered enrollment target is 60 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07610486
The ClinicalTrials.gov registry entry for NCT07610486 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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