Model-informed Precision Dosing of Vancomycin in Adults

November 30, 2023 updated by: University Hospital, Ghent

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

155

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium
        • General Hospital Sint-Jan Brugge
      • Ghent, Belgium
        • Ghent University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care Vancomycin treatment
Vancomycin standard-of-care dosing and therapeutic drug monitoring (TDM), according to institutional guidelines during 20 day study period
Drug: Vancomycin
Vancomycin treatment
Other Names:
  • Vancomycin treatment
Experimental: Vancomycin model-informed precision dosing
Area Under the Concentration-time curve ((AUC)/Minimal Inhibitory Concentration (MIC)-based model-informed precision dosing of vancomycin using a dosing calculator during 20 day study period
Drug: Vancomycin
Vancomycin treatment
Other Names:
  • Vancomycin treatment
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
Other Names:
  • Dosing calculator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 to 72 hours after start vancomycin treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first
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
72 to 96 hours after start vancomycin treatment
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
From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From start date of vancomycin treatment until date of first vancomycin target attainment or study day 20, whichever comes first
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.
From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first
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
From start date of vancomycin treatment until date of first vancomycin target attainment or study day 20, whichever comes first
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
From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first
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
From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Pieter De Cock, Prof, University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2021

Primary Completion (Actual)

November 17, 2023

Study Completion (Actual)

November 17, 2023

Study Registration Dates

First Submitted

May 13, 2022

First Submitted That Met QC Criteria

September 7, 2022

First Posted (Actual)

September 10, 2022

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC-10433
  • 2021-003670-31 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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