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NCT07822243
Tissue Penetration of Antibiotics in CriTically Ill Children
Conditions: Pediatric Critical Illness, Critical Illness
Sex: All
Ages: 1 Month – 15 Years
Healthy volunteers: No
Enrollment: 60
Sponsor: University Hospital, Ghent
Location: Ghent University Hospital Ghent
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07822243). StuddyBuddy aggregates publicly available trial information.