A multicentric randomised controlled clinical trial to study the impact of bedside model-informed precision dosing of vancomycin in critically ill children.

Phase 1

• Conditions: Gram positive infection; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-004538-40-BE
• Lead Sponsor: Ghent University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-08
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 390

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified