Model-informed Precision Dosing of Vancomycin in Adults

  • STATUS
    Recruiting
  • End date
    Sep 16, 2024
  • participants needed
    118
  • sponsor
    University Hospital, Ghent
Updated on 7 October 2022

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.

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.

Details
Condition Vancomycin
Treatment Vancomycin, vancomycin model-informed precision dosing
Clinical Study IdentifierNCT05535075
SponsorUniversity Hospital, Ghent
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

years or older
admitted to a participating ward unit
a suspected or confirmed Gram positive infection
planned to start of started on intravenous continuous infusion vancomycin treatment
participant or legal representative signed the informed consent form
not previously enrolled in this trial

Exclusion Criteria

serum creatinine level at inclusion is above 2.5 mg/dL
undergoing extracorporeal treatment at inclusion (e.g. extracorporeal membrane oxygenation, dialysis, body cooling)
patient death is deemed imminent and inevitable
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