Model-informed Precision Dosing of Vancomycin in Adults
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
| 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:
|
| 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 |
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:
Drug: Vancomycin
Vancomycin treatment
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients reaching target 24h AUC/MIC [48 to 72 hours after start vancomycin treatment]
Therapeutic AUC/MIC target range is 400-600
Secondary Outcome Measures
- 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]
AKI categories are defined according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria from stage 1 to 3 (worst)
- Proportion of patients reaching target 24h AUC/MIC [72 to 96 hours after start vancomycin treatment]
Therapeutic AUC/MIC target range is 400-600
- Proportion of time within therapeutic target [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
Other Outcome Measures
- 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]
An additional blood sample is defined as a sample for vancomycin TDM taken at another timepoint of routine biochemical monitoring samples.
- Cumulative number of (additional) blood samples [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.
- 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]
Target in Model-Informed Precision Dosing arm: 24h AUC/MIC : 400-600; in comparator arm: target concentration range according to institutional guidelines
- Cumulative vancomycin dose [From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first]
Total cumulative exposure (AUC) during treatment
- Cumulative vancomycin AUC [From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first]
Total exposure (AUC) during treatment
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | General Hospital Sint-Jan Brugge | Brugge | Belgium | ||
| 2 | Ghent University Hospital | Ghent | Belgium |
Sponsors and Collaborators
- University Hospital, Ghent
Investigators
- Principal Investigator: Pieter De Cock, Prof, University Hospital, Ghent
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BC-10433
- 2021-003670-31