Status:
COMPLETED
Clinical Decision Support Tool for Vancomycin Dosing in Children
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
Center for Translational Medicine at the School of Pharmacy
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Gram-Positive Bacterial Infections
Vancomycin
Eligibility:
All Genders
Up to 18 years
Phase:
NA
Brief Summary
This study will evaluate the pharmacokinetic and pharmacodynamic dosing properties of intravenous vancomycin in pediatric patients using a novel computer decision support (CDS) tool called Lyv. Dosing...
Detailed Description
This study is a prospective pharmacokinetic study of pediatric patients receiving IV vancomycin at the University of Maryland. Patients may be in the Pediatric Intensive Care Unit (PICU), Neonatal Int...
Eligibility Criteria
Inclusion
- Hospitalized infants and children from postmenstrual age of 38 weeks to age 19 years Requiring IV vancomycin, regardless of indication
- Parent or legally authorized representative is willing to provide permission and sign the informed consent document; subjects assent, when appropriate
- Hospitalized neonates, infants, children, adolescents who require, but have not been initiated on intravenous vancomycin therapy
Exclusion
- Patients who had received vancomycin during previous 2 weeks
- Patients with end-stage renal disease, receiving hemodialysis or receiving continuous renal replacement therapy
- On oral or intraperitoneal vancomycin
- Receiving extracorporeal therapy, including extracorporeal membrane oxygenation, continuous renal replacement therapy, and extracorporeal liver support
- Will only receive a single dose of vancomycin
- Known to be pregnant
- Is brain dead or has suspected brain death
Key Trial Info
Start Date :
May 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2025
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04911270
Start Date
May 9 2022
End Date
May 10 2025
Last Update
May 14 2025
Active Locations (1)
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1
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201