Skip to main content
OpenTrials
Completed

NCT Number: NCT04666948

Precision Dosing of Vancomycin in Critically Ill Children

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vancomycin

Age range

0 day–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Erasme, Brussels, Brussels Capital, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vancomycin model-informed precision dosing

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

Other names: dosing calculator

Vancomycin

Drug

Vancomycin treatment

Primary outcomes

  1. Proportion of patients reaching target 24hAUC/MIC

    Time frame: 24 to 48 hours after start vancomycin treatment

    therapeutic AUC/MIC target range is 400-600

Secondary outcomes

  1. Proportion of patients with (worsening) acute kidney injury during vancomycin treatment

    Time frame: from start date of vancomycin treatment until stop date vancomycin treatment or study day 30, whichever comes first

    AKI categories are defined according to the neonatal and pediatric RIFLE criteria

  2. Proportion of patients reaching target 24h AUC/MIC

    Time frame: 48-72 hours after start vancomycin treatment

    therapeutic AUC/MIC target range is 400-600

  3. Time to clinical cure

    Time frame: 30 day study period

    Time to clinical cure is defined as the time interval (in days) from start to completion of the vancomycin vancomycin treatment, without recommencement of antibiotics for the same indication within 48h after stop.

  4. Ward unit length-of-stay

    Time frame: 30 day study period

    Ward unit length-of-stay is calculated from day of ward unit admission to day of ward unit discharge.

  5. Hospital length-of-stay

    Time frame: 30 day study period

    Hospital unit length-of-stay is calculated from day of hospital admission to day of hospital discharge.

  6. 30 day all cause mortality

    Time frame: 30 day study period

    30 day all cause mortality is measured 30 days after randomisation.

Other outcomes

  1. Cumulative number of additional blood samples during treatment in patients with clinical cure

    Time frame: from start date of vancomycin treatment until stop date vancomycin treatment or study day 30, whichever comes first in patients with clinical cure

    An additional blood sample is defined as a sample for vancomycin TDM taken at another timepoint of routine biochemical monitoring samples.

  2. Number of additional blood samples to first target attainment during vancomycin treatment

    Time frame: from start date of vancomycin treatment until date of first vancomycin target attainment or study day 30, whichever comes first

    An additional blood sample is defined as a sample for vancomycin TDM taken at another timepoint of routine biochemical monitoring samples.

  3. Proportion of patients reaching target 24h AUC/MIC

    Time frame: 72-96 hours after start vancomycin treatment

    therapeutic AUC/MIC target range is 400-600

  4. Number of dose adjustments to first target attainment

    Time frame: from start date vancomycin treatment until date of first vancomycin target attainment or study day 30, whichever comes first

    Target in Model-Informed Precision Dosing arm: 24h AUC/MIC : 400-600; in comparator arm: target concentration range according to institutional guidelines

  5. Number of trough sampling time errors

    Time frame: from start date of vancomycin treatment until stop date vancomycin treatment or study day 30, whichever comes first

    only measured for intermittent dosing regimens in the comparator arm.

  6. Cumulative vancomycin dose and AUC

    Time frame: from start date of vancomycin treatment until stop date vancomycin treatment or study day 30, whichever comes first

    Total cumulative dose and exposure (AUC) during treatment

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Belgium Health Care Knowledge Centre
  • University Ghent

Registry information

Official study title

A Multicentric, Randomised Controlled Clinical Trial to Study the Impact of Bedside Model-informed Precision Dosing of Vancomycin in Critically Ill Children

Acronym: BENEFICIAL

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Dec 14, 2020
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.