Precision Dosing of Beta-lactam Antibiotics in Critically Ill Children
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age0-18
SponsorUniversity Hospital, Ghent
About this trial
The overall objective of this study is to investigate the impact of early model-informed precision dosing (MIPD) on target attainment of three beta-lactam antibiotics (amoxicillin-clavulanic acid, piperacillin-tazobactam and meropenem) in critically ill children. This evaluation includes a comparison with the more standard approach on clinical and patient-oriented measures.
Eligibility criteria
Qualifiers
Subject aged between 0 - 17 years 10 months.
Subject admitted to a participating ward unit (Neonatal Intensive Care Unit, Pediatric Intensive Care Unit, Pediatric Hematology-Oncology unit).
Strongly suspected or confirmed systemic infection.
Subject planned to start on intravenous amoxicillin-clavulanic acid, piperacillin-tazobactam or meropenem treatment at least aimed for a minimum duration of two days at time of inclusion. If the subject was previously treated with the same beta-lactam, the minimum interval to the previous beta-lactam treatment episode is
Disqualifiers
Subject with serum creatinine level ≥ 2 mg/L at inclusion.
Subject receiving (or planned to receive) haemofiltration, extracorporeal membrane oxygenation, hemodialysis or peritoneal dialysis, molecular adsorbent recirculating system or any other exchange technique.
Subject receiving (or planned to receive) body cooling.
Subject death is deemed imminent and inevitable.
Trial design
Treatments tested in this trial
- Beta-lactam antibiotic
- Beta-lactam model-informed precision dosing
Treatment groups
58 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov