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Tissue Penetration of Antibiotics in CriTically Ill Children

Study acronym: TACTIC
StatusRecruiting
PhaseNot specified
Started
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Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07822243
Lead Sponsor University Hospital, Ghent
Conditions
(from sponsor)
Pediatric Critical Illness, Critical Illness
Related terms Critical Illness
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov