Clinical trial NCT05535075: Model-informed Precision Dosing of Vancomycin in Adults
Official title: Impact of Model-informed Precision Dosing of Vancomycin in Adults: a Randomized, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vancomycin
Keywords: vancomycin
model-informed precision dosing
dose calculator
non-critically ill adults
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients reaching target 24h AUC/MIC
timeFrame: 48 to 72 hours after start vancomycin treatment
Secondary outcomes:
measure: Proportion of patients with (worsening) acute kidney injury (AKI) during vancomycin treatment
timeFrame: From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first
measure: Proportion of patients reaching target 24h AUC/MIC
timeFrame: 72 to 96 hours after start vancomycin treatment
measure: Proportion of time within therapeutic target
timeFrame: From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first
Other outcomes:
measure: Number of (additional) blood samples to first target attainment during vancomycin treatment
timeFrame: From start date of vancomycin treatment until date of first vancomycin target attainment or study day 20, whichever comes first
measure: Cumulative number of (additional) blood samples
timeFrame: From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first
measure: Number of dose adjustments to first target attainment
timeFrame: From start date of vancomycin treatment until date of first vancomycin target attainment or study day 20, whichever comes first
measure: Cumulative vancomycin dose
timeFrame: From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first
measure: Cumulative vancomycin AUC
timeFrame: From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first
Locations:
city: Brugge
country: Belgium
facility: General Hospital Sint-Jan Brugge
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Pieter De Cock, Prof
role: PRINCIPAL_INVESTIGATOR
References: