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Tissue Penetration of Antibiotics in CriTically Ill Children

Recruitingn/aAges 1 Month - 15 YearsAllUniversity Hospital, Ghent
NCT07822243 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 pa

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patient admitted to the Pediatric Intensive Care Unit (PICU). * Age: 1 month to 15 years. * Receiving intravenous antibiotic treatment with piperacillin-tazobactam, meropenem, or amoxicillin-clavulanic acid. * Receiving continuous analgosedation (required for microdialysis catheter insertion; if analgosedation is stopped after insertion, the catheter may remain in place). * Intra-arterial (preferred) or intravenous access available for blood sampling. Exclusion Criteria: * Presence of coagulopathy and/or thrombocytopenia: * Platelet count \< 50,000/µL * International Normalized Ratio (INR) \> 1.5 * Activated partial thromboplastin time (aPTT) \> 1.5 x upper limit of normal value (age-specific thresholds: \> 50 sec for 30-90 days; \> 42 sec for 90-180 days; \> 38 sec for \> 180 days) * Personal or family history of excessive bleeding. * Current treatment with coumarin derivative anticoagulants. * Known hypersensitivity to beta-lactam antibiotics. * Pregnancy. * Absence of parental (or legal guardian) informed consent. * Absence of suitable catheter for blood sampling.
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What it tests

  • Pharmacokinetic sampling (Microdialysis and blood sampling)
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Where

1 site
Ghent University Hospital
Ghent, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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