How well beta-lactam antibiotics reach tissue in critically ill children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, observational pharmacokinetic study in a single center. It uses microdialysis to measure unbound antibiotic concentrations in interstitial tissue fluid during initial dosing and at steady state in pediatric patients with critical illness who are receiving piperacillin-tazobactam, meropenem, or amoxicillin-clavulanic acid. The study also looks at how patient characteristics affect antibiotic disposition in muscle tissue. Microdialysis catheters are placed in muscle with continuous analgesia for sampling, alongside blood measurements to compare tissue and plasma levels. The goal is to see if tissue drug levels meet predefined pharmacokinetic/pharmacodynamic targets to inform dosing in this vulnerable population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ghent University Hospital
  Ghent, Belgium Recruiting

Study contacts

• Principal investigator: Pieter De Cock, Prof. — University Hospital, Ghent
• Study coordinator: Pieter De Cock, Prof.
• Email: pieter.decock@uzgent.be
• Phone: +32 9 332 29 69

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.