NCT04666948

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2020

Longer than P75 for phase_4

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 14, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

December 28, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

November 28, 2020

Last Update Submit

January 15, 2026

Conditions

Vancomycin

Keywords

vancomycinmodel-informed precision dosingcritically ill childrendose calculator

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients reaching target 24hAUC/MIC

    therapeutic AUC/MIC target range is 400-600

    24 to 48 hours after start vancomycin treatment

Secondary Outcomes (6)

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

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

  • Proportion of patients reaching target 24h AUC/MIC

    48-72 hours after start vancomycin treatment

  • Time to clinical cure

    30 day study period

  • Ward unit length-of-stay

    30 day study period

  • Hospital length-of-stay

    30 day study period

  • +1 more secondary outcomes

Other Outcomes (6)

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

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

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

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

  • Proportion of patients reaching target 24h AUC/MIC

    72-96 hours after start vancomycin treatment

  • +3 more other outcomes

Study Arms (2)

Standard of Care Vancomycin treatment

ACTIVE COMPARATOR

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

Drug: Vancomycin

vancomycin model-informed precision dosing

EXPERIMENTAL

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

Device: vancomycin model-informed precision dosingDrug: Vancomycin

Interventions

vancomycin model-informed precision dosingDEVICE

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

Also known as: dosing calculator
vancomycin model-informed precision dosing
VancomycinDRUG

Vancomycin treatment

Standard of Care Vancomycin treatmentvancomycin model-informed precision dosing

Eligibility Criteria

Age0 Days - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Erasme

Brussels, Brussels Capital, Belgium

Location

AZ Sint-Jan Brugge-Oostende AV

Bruges, Belgium

Location

Cliniques universitaires de Saint Luc

Brussels, Belgium

Location

Hopital universitaire de Reine Fabiola

Brussels, Belgium

Location

UZ Brussel

Brussels, Belgium

Location

Ghent University Hospital

Ghent, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

MeSH Terms

Interventions

Vancomycin

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Pieter De Cock, Prof

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2020

First Posted

December 14, 2020

Study Start

December 28, 2020

Primary Completion

December 14, 2023

Study Completion

October 30, 2024

Last Updated

January 16, 2026

Record last verified: 2026-01

Locations

BE(7)