Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 72 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04916951
The ClinicalTrials.gov registry entry for NCT04916951 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Amoxicillin is the first listed.
NCT04916951 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.