NCT05535075

Model-informed Precision Dosing of Vancomycin in Adults

Impact of Model-informed Precision Dosing of Vancomycin in Adults: a Randomized, Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall objective of this project is to investigate the utility of model-informed precision dosing (MIPD) of vancomycin in non-critically ill adults. 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 individual patient is challenging. Currently, the vancomycin dose is 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 non-critically ill adults, 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 and a reduction in patient burden.

Conditions

• Vancomycin

Interventions

Type	Name	Description
DEVICE	Vancomycin model-informed precision dosing	A dosing calculator is used for a posteriori calculation of vancomycin dose using a target AUC/MIC between 400-600 mg\*h/L
DRUG	Vancomycin	Vancomycin treatment

Timeline

• Start date: 2021-11-12
• Primary completion: 2023-11-17
• Completion: 2023-11-17
• First posted: 2022-09-10
• Last updated: 2023-12-01

Locations

2 sites across 1 country: Belgium