Model-Informed Precision Dosing on Amikacin and Vancomycin Therapy in Critically Ill Children

Hacettepe University

Status

Completed

Conditions

Model Informed Precision Dosing

Treatments

Device: MIPD Tool

Study type

Interventional

Funder types

Other

Identifiers

NCT07315438

Neo-MIPD

Details and patient eligibility

About

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.

Enrollment

41 patients

Sex

All

Ages

38 to 81 months old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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