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Precision Dosing of Beta-lactam Antibiotics in Critically Ill Children

NCT06929702 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-04-16

No results posted yet for this study

Summary

The overall objective of this study is to investigate the impact of early model-informed precision dosing (MIPD) on target attainment of three beta-lactam antibiotics (amoxicillin-clavulanic acid, piperacillin-tazobactam and meropenem) in critically ill children. This evaluation includes a comparison with the more standard approach on clinical and patient-oriented measures.

Conditions

  • Amoxicillin-clavulanate
  • Piperacillin-tazobactam
  • Meropenem

Interventions

DRUG

Beta-lactam antibiotic

amoxicillin-clavulanic acid, piperacillin-tazobactam, meropenem treatment

DEVICE

Beta-lactam model-informed precision dosing

A dosing calculator is used for the prediction of starting doses (a priori dose predictions) and follow-up doses (a posteriori calculations), using a target 100% fT\>MIC.

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Evelyn Dhont, Dr. · Ghent University Hospital, Princess Elisabeth Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-22
Primary Completion
2027-10-01
Completion
2027-10-01

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06929702 on ClinicalTrials.gov