NCT04666948

Precision Dosing of Vancomycin in Critically Ill Children

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 314 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 0 Days – 15 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Vancomycin

Interventions

Type	Name	Description
DEVICE	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
DRUG	Vancomycin	Vancomycin treatment

Timeline

• Start date: 2020-12-28
• Primary completion: 2023-12-14
• Completion: 2024-10-30
• First posted: 2020-12-14
• Last updated: 2026-01-16

Locations

7 sites across 1 country: Belgium