Precision Dosing of Vancomycin in Critically Ill Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

314 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-28

Study Completion Date

2024-10-30

Brief Summary

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The overall objective of this project is to investigate the large-scale utility of MIPD of vancomycin at point-of-care in ICU children. This evaluation includes a comparison with the more standard approach on Clinical and patient-oriented measures.

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Detailed Description

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Vancomycin is an antibiotic with a narrow therapeutic-toxic margin. This means that the minimum and maximum target blood target levels differ little from each other. Too low concentrations will reduce the effect of the antibiotic; higher concentrations may result in serious side effects, including renal toxicity. Vancomycin dosing tailored to the critically ill child is challenging.

Currently, the starting dose of vancomycin is calculated on a milligram per kilogram basis, which is the same for all patients. The dose is then adjusted based on a measured vancomycin blood concentration (if too high or too low). Despite this measurement, quickly achieving target concentrations remains a major challenge.

This multicenter, individual randomized study investigates the added value of a user-friendly computer program for calculating the vancomycin dose in critically ill children, compared to the current standard-of-care. Specifically, the investigators will study whether the use of this computer program leads to a shorter time to reach target concentrations, a reduction in the number and severity of side effects on the kidney, a reduction in patient burden, and a reduction in time to cure and duration of hospitalization.

Conditions

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Vancomycin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

participants and parents or legal representatives are blinded for the allocation to the intervention or standard-of-care arm until the end of study.

the statistician is kept blinded until after data analysis.

Study Groups

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Standard of Care Vancomycin treatment

Vancomycin standard-of-care dosing and therapeutic drug monitoring, according to institutional guidelines during 30 day study period

Group Type ACTIVE_COMPARATOR

Vancomycin

Intervention Type DRUG

Vancomycin treatment

vancomycin model-informed precision dosing

Area Under the Concentration (AUC)-time curve/MIC-based model-informed precision dosing of vancomycin using a CE labelled dosing calculator during 30 day study period

Group Type EXPERIMENTAL

vancomycin model-informed precision dosing

Intervention Type DEVICE

A CE labelled dosing calculator is used for a priori and a posteriori calculation of vancomycin dose using a target AUC between 400-600 mg\*h/L

Vancomycin

Intervention Type DRUG

Vancomycin treatment

Interventions

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vancomycin model-informed precision dosing

A CE labelled dosing calculator is used for a priori and a posteriori calculation of vancomycin dose using a target AUC between 400-600 mg\*h/L

Intervention Type DEVICE

Vancomycin

Vancomycin treatment

Intervention Type DRUG

Other Intervention Names

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dosing calculator

Eligibility Criteria

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Inclusion Criteria

* age: 0-18 years
* admitted to ICU or PHO unit
* suspected or confirmed Gram positive infection
* planned to start on intravenous intermittent or continuous infusion vancomycin treatment
* informed consent signed by parents or legal representatives
* not previously enrolled in this trial

Exclusion Criteria

* extracorporeal treatment at inclusion or started during treatment (extracorporeal membrane oxygenation, dialysis, body cooling)
* n or p RIFLE category failure at inclusion (Day 0) (see section 8.1.2. screening)
* Known chronic kidney disease as defined by the KDIGO definition as: structural or functional abnormalities of the kidney regardless of GFR for \< 3 months or GFR \< 60ml/min/1.73m² for ≥ 3 months. eGFR is estimated using the modified Schwartz equation
* patient death is deemed imminent and inevitable

Minimum Eligible Age

0 Days

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No