Gram positive infection
Conditions
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • age: 0-18 years • admitted to ICU or PHO unit • suspected or confirmed Gram positive infection • planned to start on intravenous intermittent (INT) or continuous infusion (CI) vancomycin treatment (if the patient was treated with vancomycin before inclusion : the minimum interval to previous vancomycin treatment episode is 48 hours) • informed consent signed by parents or legal representatives (details section 8.2) • not previously enrolled in this trial Are the trial subjects under 18? yes Number of subjects for this age range: 332 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • extracorporeal treatment at inclusion (extracorporeal membrane oxygenation, dialysis, body cooling) • n or p RIFLE category failure at inclusion (Day 0) • Known chronic kidney disease as defined by the KDIGO definition as: structural or functional abnormalities of the kidney regardless of GFR for < 3 months in duration or GFR < 60ml/min/1.73m² for = 3 months in duration. eGFR is measured using estimated the modified Schwartz equation • note: non-limitative list for a structural abnormality of the kidney : autosomal recessive polycystic kidney disease, bilateral kidney dysplasia, unique dysplasia of the kidney, nephrotic syndrome) • 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 AUC/MIC (400-600) between [24 to 48] 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 MIPD calculator - reduces the proportion of patients with (worsening) acute kidney injury during treatment with vancomycin, when compared to the use of SOC dosing regimens with therapeutic drug monitoring; - increases the proportion of patients reaching the therapeutic target 24h AUC/MIC (400-600) between [48-72] h after start of treatment, when compared to the use of SOC dosing regimens with therapeutic drug monitoring; - reduces the time to clinical cure, when compared to the use of SOC dosing regimens with therapeutic drug monitoring; - reduces the ward unit length-of-stay, when compared to the use of SOC dosing regimens with therapeutic drug monitoring; - reduces the hospital length-of-stay, when compared to the use of SOC dosing regimens with therapeutic drug monitoring; - reduces all cause 30 day mortality, when compared to the use of SOC dosing regimens with therapeutic drug monitoring;;Primary end point(s): •Proportion of patients reaching target 24hAUC (400-600);Timepoint(s) of evaluation of this end point: between 24 and 48h after start | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of patients with (worsening) AKI during vancomycin treatment • Proportion of patients reaching target 24hAUC (400-600) between [48 to 72] h after start treatment • Time to clinical cure • Ward unit length-of-stay • Hospital length-of-stay • 30 day mortality ;Timepoint(s) of evaluation of this end point: up to 30 days after start dosing. | — |
Countries
Belgium
Contacts
Public ContactHiruz CTU
Ghent University Hospital
Outcome results
None listed