Cefadroxil and Cephalexin Drug Levels and Dosing in Pediatric Musculoskeletal Infections

Completed · Phase 1

Conditions studied: Osteomyelitis, Septic Arthritis, Pyomyositis

In brief

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.

Key facts

Study ID: NCT03802552
Run by: University of Colorado, Denver
People needed: 17
Starts: 2019-05-01
Expected to finish: 2021-04-30
Last updated by the study team: 2021-06-02

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Children who are admitted to Children's Hospital Colorado and:
Are to be treated for a deep musculoskeletal infection (osteomyelitis, septic arthritis, pyomyositis), as determined by their primary medical team
Are aged 6 months to 18 years

You may not qualify if…

Patients will be excluded if they:
Are less than 6 months of age or greater than 18 years of age
Weigh less than 5.5 kg
Weigh greater than the 95%ile for age
Have underlying current renal disease based on medical history
Have an underlying chronic medical condition-examples include cystic fibrosis, sickle cell anemia, inflammatory bowel disease, pancreatitis, hepatitis, immunodeficiency, cancer, spina bifida, chromosomal abnormalities, cerebral palsy, or metabolic disorders.
Have a history of significant drug allergy to any beta-lactam antibiotic (e.g. anaphylaxis and/or angioedema)
Are on an oral cephalosporin at time of enrollment
Are started on an oral cephalosporin during the study
o Note: If an enrolled patient is started on an oral cephalosporin prior to completion of the study, they will be removed from the study. However, data obtained prior to their receipt of an oral cephalosporin will still be included in the analysis.
Are known to be pregnant

Where it is running

Children's Hospital Colorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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