KCE-181128: A Multicentric, Randomised Controlled Clinical Trial To Study The Impact Of Bedside Model-Informed Precision Dosing Of Vancomycin In Critically Ill Children - BENEFICIAL

Summary (French or Dutch)

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 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, it is investigated 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.

Trial Description
Title

A Multicentric, Randomised Controlled Clinical Trial To Study The Impact Of Bedside Model-Informed Precision Dosing Of Vancomycin In Critically Ill Children

Participants (P)

Critically ill children started on intravenous vancomycin treatment.

Intervention (I)

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

Control (C)

Vancomycin standard-of-care dosing and therapeutic drug monitoring, according to institutional guidelines.

Outcome (O)

Proportion of patients reaching target 24hAUC/MIC between 24 and 48h after start vancomycin treatment.

Trial Design

Prospective, multicentric, individual randomised controlled trial.

Sample Size

390 patients

Trial duration

28 months

Budget

€1.26M

Status

Open

 

Trial team

Sponsor

UZ Gent

Chief Investigator

Dr. Pieter De Cock

Number of participating sites

8 hospitals

14 wards

External partner

Insight RX

Documents
Protocol  
Report

Q2/2023

Publication

 

References

Clinicaltrials.gov: pending

Webpage: 

Funding scheme

2018 Investigator led