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OpenTrials
Completed

NCT Number: NCT07315438

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

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.

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Key information

Conditions

Model Informed Precision Dosing

Age range

38 month–81 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MIPD Tool

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.

Primary outcomes

  1. Predictive Accuracy of Model-Informed Precision Dosing (MIPD) Based on Median Absolute Error (MdAE)

    Time frame: From first therapeutic drug monitoring (TDM) sample to second TDM sample (typically within 3-5 days of therapy)

    Predictive accuracy of the pharmacokinetic model will be evaluated by calculating the Median Absolute Error (MdAE) between model-predicted and observed antibiotic serum concentrations. MdAE was prespecified as the primary accuracy metric due to its robustness to outliers in small pediatric samples.

  2. Predictive Accuracy of Model-Informed Precision Dosing (MIPD) Based on Mean Absolute Error (MAE)

    Time frame: From first therapeutic drug monitoring (TDM) sample to second TDM sample (typically within 3-5 days of therapy)

    Mean Absolute Error (MAE) between model-predicted and observed serum antibiotic concentrations will be calculated to assess overall prediction error.

  3. Predictive Accuracy of Model-Informed Precision Dosing (MIPD) Based on Median Error (MdE)

    Time frame: From first therapeutic drug monitoring (TDM) sample to second TDM sample (typically within 3-5 days of therapy)

    Median Error (MdE) will be calculated to evaluate directional bias between predicted and observed serum antibiotic concentrations.

Secondary outcomes

  1. Change in C-Reactive Protein (CRP) Level

    Time frame: Baseline to approximately day 3-5 of therapy

    The absolute change in serum C-reactive protein (CRP) level from baseline (within 24 hours of antibiotic initiation) to the time of the second TDM sample will be evaluated as an inflammatory response marker.

  2. Change in Procalcitonin Level

    Time frame: Baseline to approximately day 3-5 of therapy

    The absolute change in serum procalcitonin level from baseline to the time of the second TDM sample will be assessed.

  3. Change in Serum Creatinine Level

    Time frame: Baseline to approximately day 3-5 of therapy

    The absolute change in serum creatinine level from baseline to the time of the second TDM sample will be evaluated as a marker of renal safety.

  4. Change in Pharmacokinetic Model-Fit Category

    Time frame: From first to second TDM sample (typically within 3-5 days)

    Within-patient change in pharmacokinetic model-fit category (poor, intermediate, good) between the first and second TDM measurements will be assessed to evaluate improvement in model performance after Bayesian updating.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Model-Informed Precision Dosing on Amikacin and Vancomycin Therapy in Critically Ill Children: A Pilot Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.