Precision Dosing of Beta-lactam Antibiotics in Critically Ill Children

Launched by UNIVERSITY HOSPITAL, GHENT · Apr 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how to give the right amount of certain antibiotics, specifically amoxicillin-clavulanate, piperacillin-tazobactam, and meropenem, to critically ill children. The goal is to see if a new method called model-informed precision dosing (MIPD) can help ensure that these children receive the right dose of medication more effectively than the standard approach. By doing this, researchers hope to improve treatment outcomes for kids with serious infections.

To be eligible for this study, children between the ages of 0 and 17 years old who are in a Neonatal Intensive Care Unit, Pediatric Intensive Care Unit, or Pediatric Hematology-Oncology unit may participate if they have a suspected or confirmed infection and are expected to start treatment with one of the three antibiotics for at least two days. Parents or legal guardians will need to provide consent for their child to join the study. If enrolled, participants can expect to receive careful monitoring and adjustments to their medication based on how their bodies respond, helping to ensure they get the most effective treatment possible. It is important to note that some children may not qualify if they have certain medical conditions or allergies.

Gender

ALL

Eligibility criteria

• 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 treatment.
• • The subject is known or suspected to be pregnant.
• • The subject has a known allergy to the specific beta-lactam antibiotic.
• • (\*) The first (a posteriori) dose calculation and dose adjustment if necessary, is performed within a maximum timeframe of 28 hours after start of treatment (i.e. maximum timeframe to first dose adjustment).