Precision Dosing of Beta-lactam Antibiotics in Critically Ill Children (NCT06929702) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Precision Dosing of Beta-lactam Antibiotics in Critically Ill Children
Belgium58 participantsStarted 2025-04-22
Plain-language summary
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.
Who can participate
Age range0 Years – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 40 hours for amoxicillin-clavulanic acid (based on elimination half-life)
* 8 hours for piperacillin-tazobactam and meropenem (based on elimination half-life) Subject planned to start on intravenous amoxicillin (without clavulanic acid) will not be included.
* Informed consent/assent signed by parents or legal representatives of the subject.
* Not previously enrolled in this trial.
Exclusion Criteria:
* 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.
* Reporting of first dosing advice (based on blood sampling) is not possible within 28 hours (\*) after start treatmen…
What they're measuring
1
Proportion of subjects reaching the therapeutic target 100% fT>MIC
Timeframe: At 48 hours after start of beta-lactam treatment