KCE-181128: Eine multizentrische, randomisierte, kontrollierte klinische Studie zur Untersuchung der Auswirkungen einer genauen Dosierung von Vancomycin durch ein Computerprogramm für schwerkranke Kinder - BENEFICIAL

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

Dokumente
Protocol  
Report

Q2/2023

Publication

 

REFERENZEN

Clinicaltrials.gov: pending

Webpage: 

FINANZIERUNGSSCHEMA

2018 Investigator led