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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Page 1 of 1 (1 locations)

1

University of Maryland Medical Center

Baltimore, Maryland, United States, 21201