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Completed

NCT Number: NCT05535075

Model-informed Precision Dosing of Vancomycin in Adults

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

General Hospital Sint-Jan Brugge, Bruges, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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.

Treatment and study plan

Vancomycin model-informed precision dosing

Device

A dosing calculator is used for a posteriori calculation of vancomycin dose using a target AUC/MIC between 400-600 mg*h/L

Other names: Dosing calculator

Vancomycin

Drug

Vancomycin treatment

Other names: Vancomycin treatment

Primary outcomes

  1. Proportion of patients reaching target 24h AUC/MIC

    Time frame: 48 to 72 hours after start vancomycin treatment

    Therapeutic AUC/MIC target range is 400-600

Secondary outcomes

  1. Proportion of patients with (worsening) acute kidney injury (AKI) during vancomycin treatment

    Time frame: From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first

    AKI categories are defined according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria from stage 1 to 3 (worst)

  2. Proportion of patients reaching target 24h AUC/MIC

    Time frame: 72 to 96 hours after start vancomycin treatment

    Therapeutic AUC/MIC target range is 400-600

  3. Proportion of time within therapeutic target

    Time frame: From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first

    Therapeutic AUC/MIC target range is 400-600

Other outcomes

  1. Number of (additional) blood samples to first target attainment during vancomycin treatment

    Time frame: From start date of vancomycin treatment until date of first vancomycin target attainment or study day 20, whichever comes first

    An additional blood sample is defined as a sample for vancomycin TDM taken at another timepoint of routine biochemical monitoring samples.

  2. Cumulative number of (additional) blood samples

    Time frame: From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first

    An additional blood sample is defined as a sample for vancomycin TDM taken at another timepoint of routine biochemical monitoring samples.

  3. Number of dose adjustments to first target attainment

    Time frame: From start date of vancomycin treatment until date of first vancomycin target attainment or study day 20, whichever comes first

    Target in Model-Informed Precision Dosing arm: 24h AUC/MIC : 400-600; in comparator arm: target concentration range according to institutional guidelines

  4. Cumulative vancomycin dose

    Time frame: From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first

    Total cumulative exposure (AUC) during treatment

  5. Cumulative vancomycin AUC

    Time frame: From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first

    Total exposure (AUC) during treatment

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 10, 2022
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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