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NCT03802552 · ClinicalTrials.gov registry record · Phase 1
Cefadroxil and Cephalexin Drug Levels and Dosing in Pediatric Musculoskeletal Infections
A Phase 1 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT03802552 is a Phase 1 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 17 participants.
The verdict
NCT03802552, a Phase 1 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
The goal of this study is to figure out the best doses for two antibiotics (called cefadroxil and cephalexin) when they are used to treat bone, joint, or muscle infections in children. In order to do this, the study will collect data about children admitted to Children's Hospital Colorado who have these types of infections. During the study, these patients will receive doses by mouth of each of these antibiotics, in addition to an IV antibiotic (given through a vein) used to treat their infection. After the dose of the first antibiotic, blood samples will be drawn every few hours to measure how much of the drug is still in their body, until it is all gone. After the first antibiotic is out of the patient's body, the same will be done for the second antibiotic. Measurements, in the lab, of how much of these antibiotics are needed to kill the most common bacteria causing these infections, which is a type of "Staph" bacteria called "MSSA", will be taken. Finally, the blood levels of the antibiotics and the information from the lab tests about the Staph bacteria will be used to calculate how much and how often of the antibiotic should be given to children with bone, joint, or muscle infections. Currently, these types of infections are treated with an antibiotic that children have to take four times every day. The goal of this study is to find an antibiotic that children can take only two or three times per day.
Interventions
- DRUG Cephalexin
- DRUG Cefadroxil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2019-05-01 |
| Est. Completion | 2021-04-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03802552
The ClinicalTrials.gov registry entry for NCT03802552 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 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 Cephalexin is the first listed.
NCT03802552 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03802552 about?
NCT03802552 is a clinical study titled "Cefadroxil and Cephalexin Drug Levels and Dosing in Pediatric Musculoskeletal Infections". The goal of this study is to figure out the best doses for two antibiotics (called cefadroxil and cephalexin) when they are used to treat bone, joint, or muscle infections in children. In order to do this, the study will collect data about children admitted to Children's Hospital Colorado who have t...
What is the current status of trial NCT03802552?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2019-05-01. Estimated completion is 2021-04-30.
What interventions are being tested in trial NCT03802552?
The interventions under investigation include: Cephalexin (DRUG), Cefadroxil (DRUG).
Who is sponsoring clinical trial NCT03802552?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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