KCE-181128: Eine multizentrische, randomisierte, kontrollierte klinische Studie zur Untersuchung der Auswirkungen einer genauen Dosierung von Vancomycin durch ein Computerprogramm für schwerkranke Kinder - BENEFICIAL
(Niederländisch oder Französisch oder Englisch)
| Title |
A Multicentric, Randomised Controlled Clinical Trial To Study The Impact Of Bedside Model-Informed Precision Dosing Of Vancomycin In Critically Ill Children |
|
Participants (P) |
Critically ill children started on intravenous vancomycin treatment. |
|
Intervention (I) |
Area Under the Concentration (AUC)-time curve/MIC-based model-informed precision dosing of vancomycin using a CE labelled dosing calculator. |
|
Control (C) |
Vancomycin standard-of-care dosing and therapeutic drug monitoring, according to institutional guidelines. |
|
Outcome (O) |
Proportion of patients reaching target 24hAUC/MIC between 24 and 48h after start vancomycin treatment. |
|
Trial Design |
Prospective, multicentric, individual randomised controlled trial. |
|
Sample Size |
390 patients |
|
Trial duration |
28 months |
|
Budget |
€1.26M |
|
Status |
Open |
