NCT06929702

Precision Dosing of Beta-lactam Antibiotics in Critically Ill Children

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 0 Years – 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-04-22
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2025-04-16
• Last updated: 2025-04-16

Locations

1 site across 1 country: Belgium