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NCT04916951 · ClinicalTrials.gov registry record · Phase 1
Oral Amoxicillin and Cephalexin PK/PD in Neonates
A Phase 1 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT04916951: Completed Phase 1 study, sponsored by University of Colorado, Denver.
NCT04916951 is a Phase 1 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04916951, a Phase 1 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
Study Summary
The goal of this study is to figure out the best doses for two oral antibiotics (called amoxicillin and cephalexin) when they are used to treat infections in newborns and young infants. In order to do this, the study plans to enroll two groups of young infants who are admitted to the Children's Hospital Colorado. In the first group, infants already receiving one of these two antibiotics will be enrolled. Over a few days in the hospital, up to 5 blood samples will be collected from each infant to measure how much of the drug is in their body at different points in time after a dose. In the second group, infants who are already receiving an IV antibiotic and who are eating normally or receiving oral medications will be enrolled. These infants will receive one dose by mouth of either amoxicillin or cephalexin, in addition to the IV antibiotic already being used to treat their infection. After the oral antibiotic dose,blood will be drawn every few hours to measure how much of the drug is still in their body. Blood levels of the antibiotics will be used to calculate how much and how often both antibiotics would need to be given to treat a variety of infections that are common in infants. The study will calculate if using a single blood level can predict whether or not an infant might be at risk of the antibiotic not working well enough for them.
Primary Outcome
As a surrogate of treatment efficacy for amoxicillin and cephalexin, the investigators will determine the time that free plasma concentrations (fT \> MIC) of amoxicillin and cephalexin remain above the minimum inhibitory concentration (MIC) of common neonatal pathogens. Monte Carlo simulation will be used to assess for the likelihood of fT \> MIC dosing goals.
Interventions
- DRUG Amoxicillin
- DRUG Cephalexin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2021-07-14 |
| Est. Completion | 2025-11-30 |
| Phase | Phase 1 |
What the finished NCT04916951 record still lists
NCT04916951 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 2 interventions - of which Amoxicillin is the first listed.
NCT04916951 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04916951 about?
NCT04916951 is a clinical study titled "Oral Amoxicillin and Cephalexin PK/PD in Neonates". The goal of this study is to figure out the best doses for two oral antibiotics (called amoxicillin and cephalexin) when they are used to treat infections in newborns and young infants. In order to do this, the study plans to enroll two groups of young infants who are admitted to the Children's Hosp...
What is the current status of trial NCT04916951?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2021-07-14. Estimated completion is 2025-11-30.
What interventions are being tested in trial NCT04916951?
The interventions under investigation include: Amoxicillin (DRUG), Cephalexin (DRUG).
Who is sponsoring clinical trial NCT04916951?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04916951's enrollment target sits among peer trials
72 736th of 2000 higher than 1,254 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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