Status:
COMPLETED
Cefadroxil and Cephalexin Drug Levels and Dosing in Pediatric Musculoskeletal Infections
Lead Sponsor:
University of Colorado, Denver
Conditions:
Osteomyelitis
Septic Arthritis
Eligibility:
All Genders
6-18 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
This study aims to shift the current treatment paradigm for the use of oral first-generation cephalosporins in pediatric musculoskeletal (MSK) infections. Optimizing treatment for MSK infections is pa...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2021
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03802552
Start Date
May 1 2019
End Date
April 30 2021
Last Update
June 2 2021
Active Locations (1)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045