Model-informed Precision Dosing of Vancomycin in Adults

Vancomycin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05535075
• Other study ID #: BC-10433
• Secondary ID: 2021-003670-31
• Status: Completed
• Phase: Phase 4
• Start date: November 12, 2021
• Est. completion date: November 17, 2023

Study information

• Verified date: November 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: November 17, 2023
• Est. primary completion date: November 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vancomycin

Intervention

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

Drug:
• Vancomycin
Vancomycin treatment

Locations

Country	Name	City	State
Belgium	General Hospital Sint-Jan Brugge	Brugge
Belgium	Ghent University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of (additional) blood samples to first target attainment during vancomycin treatment	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
Other	Cumulative number of (additional) blood samples	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
Other	Number of dose adjustments to first target attainment	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
Other	Cumulative vancomycin dose	Total cumulative exposure (AUC) during treatment	From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first
Other	Cumulative vancomycin AUC	Total exposure (AUC) during treatment	From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first
Primary	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	Proportion of patients with (worsening) acute kidney injury (AKI) during vancomycin treatment	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
Secondary	Proportion of patients reaching target 24h AUC/MIC	Therapeutic AUC/MIC target range is 400-600	72 to 96 hours after start vancomycin treatment
Secondary	Proportion of time within therapeutic target	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