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

NCT ID: NCT07315438

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-10-27

Brief Summary

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.

Conditions

Model Informed Precision Dosing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MIPD Group

Group Type: EXPERIMENTAL

MIPD Tool

Intervention Type: DEVICE

It is a precision dosing platform that combines population pharmacokinetic/pharmacodynamic (popPK/PD) modeling with artificial intelligence and machine learning to optimize individualized drug therapy.

It uses patient-specific demographic, clinical, and laboratory data to generate real-time personalized dosing recommendations based on validated popPK models.

Standard of Care Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MIPD Tool

It is a precision dosing platform that combines population pharmacokinetic/pharmacodynamic (popPK/PD) modeling with artificial intelligence and machine learning to optimize individualized drug therapy.

It uses patient-specific demographic, clinical, and laboratory data to generate real-time personalized dosing recommendations based on validated popPK models.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Hospitalized patients (NICU) receiving vancomycin or amikacin
• Treatment with vancomycin or amikacin initiated during hospitalization

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

• Minimum Eligible Age: 38 Months
• Maximum Eligible Age: 81 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Nadir Yalçın

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hacettepe University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Neo-MIPD

Identifier Type: -

Identifier Source: org_study_id