Gram positive infection
Conditions
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - age: =18 years - admitted to the participating ward units (non-critically ill patients) - suspected or confirmed Gram positive infection - planned to start or started on intravenous continuous infusion (CI) vancomycin treatment (if the patient was previously treated with vancomycin, the minimum interval to a previous vancomycin treatment episode is 48 hours) - informed consent signed by the patient or legal representatives - not previously enrolled in this trial Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 107 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 73
Exclusion criteria
Exclusion criteria: - extracorporeal treatment at inclusion (extracorporeal membrane oxygenation, dialysis, body cooling) - serum creatinine level above 2.5 mg/dL at inclusion - patient death is deemed imminent and inevitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study will test the primary hypothesis that AUC/MIC based vancomycin dosing, using a model-informed precision dosing calculator, increases the proportion of patients reaching the therapeutic target AUC24u/MIC (400-600) between [48-72] h after start of treatment, when compared to the use of standard-of-care dosing regimens with therapeutic drug monitoring.;Secondary Objective: to test hypotheses that AUC/MIC based vancomycin dosing, using a model-informed precision dosing calculator - reduces the number of (additional) blood samples to first target attainment, when compared to the use of standard-of-care dosing regimens with therapeutic drug monitoring; - reduces the cumulative number of (additional) blood samples during treatment, when compared to the use of standard-of-care dosing regimens with therapeutic drug monitoring; - reduces the number of dose adjustments to first target attainment during treatment, when compared to the use of standard-of-care dosing regimens with therapeutic drug monitoring; - reduces the cumulative vancomycin dose and corresponding AUC during vancomycin treatment, when compared to the use of standard-of-care dosing regimens with therapeutic drug monitoring. ;Primary end point(s): Proportion of patients reaching target AUC24h/MIC (400-600) ;Timepoint(s) of evaluation of this end point: between 48h and 72h after start of vancomycin treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Proportion of patients with (worsening) AKI during and until 48h after stop of vancomycin treatment - Proportion of patients reaching target 24hAUC (400-600) between [72 to 96] h after start of vancomycin treatment - Proportion of time within target 24hAUC (400-600);Timepoint(s) of evaluation of this end point: stop date treatment | — |
Countries
Belgium
Contacts
Public ContactHIRUZ
Ghent University Hospital
Outcome results
None listed