Achieving optimal antibiotic exposure in critically ill pediatric patients is difficult due to (their) dynamic physiology and variability. Conventional weight-based regimens often fail to reach pharmacokinetic/pharmacodynamic (PK/PD) targets for narrow therapeutic index agents such as vancomycin and amikacin. Model-Informed Precision Dosing (MIPD), which integrates Bayesian forecasting with population pharmacokinetics (popPK), offers a potentially valuable yet underexplored approach in pediatric intensive care to better attain and sustain target exposure. This pilot randomized clinical trial evaluated MIPD-guided dosing of vancomycin and amikacin using InsightRX Nova® versus standard of care (SoC) in a tertiary PICU. Patients whose model-recommended doses matched standard regimens were analyzed under SoC. Primary outcomes included prediction accuracy (a priori vs a posteriori) and model fit; secondary outcomes assessed dose optimization, inflammatory response, renal safety, treatment duration, and mortality.

Inclusion Criteria

• Hospitalized patients (NICU) receiving vancomycin or amikacin
• Treatment with vancomycin or amikacin initiated during hospitalization
• At least one therapeutic drug monitoring (TDM) measurement obtained Exclusion Criteria
• Failure to obtain written informed consent
• Death within the first 24 hours after treatment initiation
• Discontinuation of therapy before the first TDM measurement
• Determined unsuitable for study participation by the treating physician