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Not yet recruiting NCT06929702

Precision Dosing of Beta-lactam Antibiotics in Critically Ill Children

Phase IV Interventional Amoxicillin-clavulanate Piperacillin-tazobactam Meropenem

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Beta-lactam antibiotic, Beta-lactam model-informed precision dosing.
Who it may be relevant to
Registry conditions: Amoxicillin-clavulanate, Piperacillin-tazobactam, Meropenem. Basic parameters: 0 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Early Model-Informed Precision Dosing of Beta-lactam Antibiotics in Critically Ill Children: Big Solution for Small People?

Overview

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.

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.

Primary outcome measures

  • Proportion of subjects reaching the therapeutic target 100% fT>MIC [Time frame: At 48 hours after start of beta-lactam treatment]
Secondary outcome measures (3)
  • Proportion of subjects reaching the therapeutic target 100% fT>MIC [Time frame: At 120 hours after start of beta-lactam treatment]
  • Proportion of subjects reaching the therapeutic target 100% fT>MIC [Time frame: Within the interval 48 to 72 hours after start of beta-treatment]
  • Hospital length-of-stay [Time frame: From date of randomization until date of hospital discharge, with a maximum of 28 days.]

Eligibility criteria

Inclusion criteria

  • Subject aged between 0 - 17 years 10 months.
  • Subject admitted to a participating ward unit (Neonatal Intensive Care Unit, Pediatric Intensive Care Unit, Pediatric Hematology-Oncology unit).
  • Strongly suspected or confirmed systemic infection.
  • Subject planned to start on intravenous amoxicillin-clavulanic acid, piperacillin-tazobactam or meropenem treatment at least aimed for a minimum duration of two days at time of inclusion. If the subject was previously treated with the same beta-lactam, the minimum interval to the previous beta-lactam treatment episode is
  • 40 hours for amoxicillin-clavulanic acid (based on elimination half-life)
  • 8 hours for piperacillin-tazobactam and meropenem (based on elimination half-life) Subject planned to start on intravenous amoxicillin (without clavulanic acid) will not be included.
  • Informed consent/assent signed by parents or legal representatives of the subject.
  • Not previously enrolled in this trial.

Exclusion criteria

  • Subject with serum creatinine level ≥ 2 mg/L at inclusion.
  • Subject receiving (or planned to receive) haemofiltration, extracorporeal membrane oxygenation, hemodialysis or peritoneal dialysis, molecular adsorbent recirculating system or any other exchange technique.
  • Subject receiving (or planned to receive) body cooling.
  • Subject death is deemed imminent and inevitable.
  • Reporting of first dosing advice (based on blood sampling) is not possible within 28 hours (\*) after start treatment.
  • The subject is known or suspected to be pregnant.
  • The subject has a known allergy to the specific beta-lactam antibiotic.

(\*) The first (a posteriori) dose calculation and dose adjustment if necessary, is performed within a maximum timeframe of 28 hours after start of treatment (i.e. maximum timeframe to first dose adjustment).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • Ghent University Hospital — Ghent

Identifiers

NCT: NCT06929702 · ONZ-2024-0295 · 2024-516447-12-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗