Model-informed Precision Dosing of Vancomycin in Adults

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 4

Conditions: Vancomycin

Treatments: Drug: Vancomycin; Device: Vancomycin model-informed precision dosing

Study type: Interventional

Funder types: Other

Identifiers

NCT05535075

2021-003670-31 (EudraCT Number)

BC-10433

Details and patient eligibility

About

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.

Full 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.

Enrollment: 155 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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155 participants in 2 patient groups

Standard of Care Vancomycin treatment

Active Comparator group

Description:

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

Treatment:

Drug: Vancomycin

Vancomycin model-informed precision dosing

Experimental group

Description:

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

Treatment:

Device: Vancomycin model-informed precision dosing

Drug: Vancomycin