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.
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 |
Sponsor |
UZ Gent |
Chief Investigator |
Dr. Pieter De Cock |
Number of participating sites |
8 hospitals 14 wards |
External partner |
Insight RX |
Clinicaltrials.gov: NCT04666948
Webpage: www.uzgent.be/beneficial
2018 Investigator led