CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 75 enrolled
Drug / intervention
Computer Decision Support Tool Intervention Group +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04911270
NCT04911270N/ACompleted
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A Pharmacokinetic Study to Evaluate the Use of a Novel Clinical Decision Support Tool, Lyv, in Achieving AUC24/MIC > 400 in Pediatric Patients on Vancomycin

University of Maryland, Baltimore·interventional·Posted Jun 3, 2021·Updated May 14, 2025

In Brief

A clinical study evaluating Computer Decision Support Tool Intervention Group and Matched Historical Controls for Gram-Positive Bacterial Infections and 3 related conditions. Completed, enrolled 75 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGram-Positive Bacterial Infections, Vancomycin, Pharmacokinetics, Pharmacodynamics
CountriesUnited States
CollaboratorsCenter for Translational Medicine at the School of Pharmacy, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJun 3, 2021
Enrollment StartMay 9, 2022
Primary CompletionApr 12, 2024
Study CompletionMay 10, 2025
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 5.1 years ago

Interventions

Computer Decision Support Tool Intervention Groupdevice

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

Matched Historical Controlsother

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