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Early Onset Sepsis / Ampicillin prescribed by provider per standard of care for evaluation of early o / Preterm Neonates · Phase 1/2 Trial
ClinicalTrials.gov · August 5, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1/2 registry record for an ongoing trial evaluating whether preterm infants can safely receive shortened (24–36 hour) ampicillin courses instead of standard 48-hour therapy, with measurement of plasma ampicillin concentration and clinical safety follow-up to 30 days. No results have been posted in this registry record; the trial is actively recruiting and the primary outcome data are planned but not yet reported.
Phase 1/2, Interventional, Single Group, Open label, Treatment purpose. Early Onset Sepsis, Preterm Neonates, NICU, Ampicillin, Safety and Pharmacokinetics; age from 0 Days; to 7 Days. Intervention: Short-course Ampicillin. Compared with: Implicit historical/standard comparator: standard 48-hour ampicillin course (not a formal control arm in this study). n = 60. 1 site: United States.
This is a Phase 1/2 registry record for an ongoing trial evaluating whether preterm infants can safely receive shortened (24–36 hour) ampicillin courses instead of standard 48-hour therapy, with measurement of plasma ampicillin concentration and clinical safety follow-up to 30 days. No results have been posted in this registry record; the trial is actively recruiting and the primary outcome data are planned but not yet reported.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
Results, when available, may inform safer and shorter antibiotic courses in preterm infants, potentially reducing unnecessary prolonged exposure while maintaining adequate drug levels and clinical safety. Clinicians should not alter practice based on this registry entry, as no efficacy or safety data are yet reported.
This is an actively recruiting Phase 1/2 interventional trial with no posted results; it aims to evaluate safety and pharmacokinetics of shortened ampicillin dosing in preterm neonates but has not yet reported outcomes.
As stated by the source record.
Quoted from the source exactly as published.
Results, when available, may inform safer and shorter antibiotic courses in preterm infants, potentially reducing unnecessary prolonged exposure while maintaining adequate drug levels and clinical safety. Clinicians should not alter practice based on this registry entry, as no efficacy or safety data are yet reported.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07610486). This is a study registration, not published results. Lead sponsor: Duke University. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Early Onset Sepsis, Preterm Neonates, NICU, Ampicillin, Safety and Pharmacokinetics. Interventions: DRUG: Ampicillin prescribed by provider per standard of care for evaluation of early onset sepsis. Primary outcome measures: Total plasma ampicillin concentration , data will be collected up to 50 hours from the first dose of ampicillin. Brief 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 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
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.