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RECRUITING
NCT07822243

Tissue Penetration of Antibiotics in CriTically Ill Children

Sponsor: University Hospital, Ghent

View on ClinicalTrials.gov

Summary

This clinical study evaluates the extent to which three commonly administered beta-lactam antibiotics (piperacillin-tazobactam, meropenem, and amoxicillin-clavulanic acid) penetrate tissue in critically ill pediatric patients. The primary objectives of this study are to: * Determine whether tissue penetration of beta-lactam antibiotics is impaired in critically ill pediatric patients during initial dosing and steady-state conditions. * Evaluate whether antibiotic concentrations within interstitial tissue fluid achieve defined pharmacokinetic and pharmacodynamic targets. * Assess the impact of patient demographics and clinical characteristics on antibiotic disposition in muscle tissue. Investigators will measure unbound antibiotic concentrations in tissue fluid using microdialysis, a technique involving the placement of a microdialysis catheter into the muscle tissue. Participating patients will undergo the following procedures: * Insertion of a flexible microdialysis catheter into the vastus lateralis (thigh) muscle under continuous sedation. * Administration of the prescribed antibiotic therapy in accordance with standard medical care. * Collection of microdialysate and blood samples across specified dosing intervals to quantify tissue and plasma drug concentrations.

Official title: TACTIC Study: Tissue Penetration of Antibiotics in CriTically Ill Children

Key Details

Gender

All

Age Range

1 Month - 15 Years

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2021-10-01

Completion Date

2026-12-31

Last Updated

2026-09-16

Healthy Volunteers

No

Interventions

OTHER

Pharmacokinetic sampling (Microdialysis and blood sampling)

Intervention Description: Insertion of a 63 Microdialysis Catheter (M Dialysis AB; 20 kDa cutoff, 10 mm membrane) into the vastus lateralis muscle to measure unbound interstitial fluid antibiotic concentrations (calibrated using retrodialysis and an internal standard), combined with paired blood sampling via existing arterial/venous access to determine total and unbound plasma concentrations.

Locations (1)

Ghent University Hospital

Ghent, Belgium