NCT05535075

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2021

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 10, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2023

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

May 13, 2022

Last Update Submit

November 30, 2023

Conditions

Vancomycin

Keywords

vancomycinmodel-informed precision dosingdose calculatornon-critically ill adults

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients reaching target 24h AUC/MIC

    Therapeutic AUC/MIC target range is 400-600

    48 to 72 hours after start vancomycin treatment

Secondary Outcomes (3)

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

    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

    72 to 96 hours after start vancomycin treatment

  • Proportion of time within therapeutic target

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

Other Outcomes (5)

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

    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

    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

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

  • +2 more other outcomes

Study Arms (2)

Standard of Care Vancomycin treatment

ACTIVE COMPARATOR

Vancomycin standard-of-care dosing and therapeutic drug monitoring (TDM), according to institutional guidelines during 20 day study period

Drug: Vancomycin

Vancomycin model-informed precision dosing

EXPERIMENTAL

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

Device: Vancomycin model-informed precision dosingDrug: Vancomycin

Interventions

Vancomycin model-informed precision dosingDEVICE

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

Also known as: Dosing calculator
Vancomycin model-informed precision dosing
VancomycinDRUG

Vancomycin treatment

Also known as: Vancomycin treatment
Standard of Care Vancomycin treatmentVancomycin model-informed precision dosing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patient death is deemed imminent and inevitable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

General Hospital Sint-Jan Brugge

Bruges, Belgium

Location

Ghent University Hospital

Ghent, Belgium

Location

MeSH Terms

Interventions

Vancomycin

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Pieter De Cock, Prof

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and legal representatives are blinded for the allocation to the intervention or standard-of-care arm until the end of study. The statistician is kept blinded until after data analysis.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2022

First Posted

September 10, 2022

Study Start

November 12, 2021

Primary Completion

November 17, 2023

Study Completion

November 17, 2023

Last Updated

December 1, 2023

Record last verified: 2023-11

Locations

BE(2)