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Clinical Decision Support Tool for Vancomycin Dosing in Children

NCT04911270 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-05-14

No results posted yet for this study

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 will be individualized based on AUC24/MIC. The results will be compared to matched historical controls.

Conditions

  • Gram-Positive Bacterial Infections
  • Vancomycin
  • Pharmacokinetics
  • Pharmacodynamics

Interventions

DEVICE

Computer Decision Support Tool Intervention Group

Computer Decision Support Tool using Bayesian estimation to dose IV vancomycin in pediatric patients using AUC24/MIC

OTHER

Matched Historical Controls

Vancomycin dosing based on standard hospital methods, with dose adjustments based on vancomycin trough targets

Sponsors & Collaborators

  • Center for Translational Medicine at the School of Pharmacy

    collaborator UNKNOWN

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-09
Primary Completion
2024-04-12
Completion
2025-05-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04911270 on ClinicalTrials.gov