Vancomycin
Conditions
Keywords
vancomycin, model-informed precision dosing, critically ill children, dose calculator
Brief summary
The overall objective of this project is to investigate the large-scale utility of MIPD of vancomycin at point-of-care in ICU children. 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 critically ill child is challenging. Currently, the starting dose of vancomycin is calculated on a milligram per kilogram basis, which is the same for all patients. The dose is then 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 critically ill children, 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, a reduction in patient burden, and a reduction in time to cure and duration of hospitalization.
Interventions
A CE labelled dosing calculator is used for a priori and a posteriori calculation of vancomycin dose using a target AUC between 400-600 mg\*h/L
DRUGVancomycin
Vancomycin treatment
Sponsors
University Hospital, Ghent
Belgium Health Care Knowledge Centre
University Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
participants and parents or 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.
Eligibility
Sex/Gender
ALL
Age
0 Days to 15 Years
Healthy volunteers
No
Inclusion criteria
* age: 0-18 years * admitted to ICU or PHO unit * suspected or confirmed Gram positive infection * planned to start on intravenous intermittent or continuous infusion vancomycin treatment * informed consent signed by parents or legal representatives * not previously enrolled in this trial
Exclusion criteria
* extracorporeal treatment at inclusion or started during treatment (extracorporeal membrane oxygenation, dialysis, body cooling) * n or p RIFLE category failure at inclusion (Day 0) (see section 8.1.2. screening) * Known chronic kidney disease as defined by the KDIGO definition as: structural or functional abnormalities of the kidney regardless of GFR for \< 3 months or GFR \< 60ml/min/1.73m² for ≥ 3 months. eGFR is estimated using the modified Schwartz equation * patient death is deemed imminent and inevitable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients reaching target 24hAUC/MIC | 24 to 48 hours after start vancomycin treatment | therapeutic AUC/MIC target range is 400-600 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with (worsening) acute kidney injury during vancomycin treatment | from start date of vancomycin treatment until stop date vancomycin treatment or study day 30, whichever comes first | AKI categories are defined according to the neonatal and pediatric RIFLE criteria |
| Proportion of patients reaching target 24h AUC/MIC | 48-72 hours after start vancomycin treatment | therapeutic AUC/MIC target range is 400-600 |
| Time to clinical cure | 30 day study period | Time to clinical cure is defined as the time interval (in days) from start to completion of the vancomycin vancomycin treatment, without recommencement of antibiotics for the same indication within 48h after stop. |
| Ward unit length-of-stay | 30 day study period | Ward unit length-of-stay is calculated from day of ward unit admission to day of ward unit discharge. |
| Hospital length-of-stay | 30 day study period | Hospital unit length-of-stay is calculated from day of hospital admission to day of hospital discharge. |
| 30 day all cause mortality | 30 day study period | 30 day all cause mortality is measured 30 days after randomisation. |
Countries
Belgium
Contacts
PRINCIPAL_INVESTIGATORPieter De Cock, Prof
University Hospital, Ghent
Outcome results
None listed