Do antibiotics reach the battlefield? muscle probe tests drug delivery in sick kids
NCT ID NCT07822243
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Critically ill children often receive antibiotics, but it is unclear whether the drugs reach enough concentration in their tissues to fight infection. This study uses microdialysis, a thin catheter placed in the thigh muscle, to measure antibiotic levels directly in tissue fluid alongside blood samples. Researchers will track three common beta-lactam antibiotics in 60 children aged 1 month to 15 years who are already receiving these drugs in intensive care. The goal is to understand how well the antibiotics penetrate muscle and whether standard doses achieve target concentrations.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- microdialysis sampling of three beta-lactam antibiotics (piperacillin-tazobactam, meropenem, amoxicillin-clavulanic acid)
- What this could lead to
- If tissue levels fall short of targets, this could guide better antibiotic dosing for critically ill children and point toward changes in how these drugs are given.
- What could go wrong
- This is a small observational study of 60 children in one hospital. It measures drug levels, not whether children get better, so it cannot prove that adjusting doses improves outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2021
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population consists of critically ill pediatric patients aged 1 month to 15 years admitted to the Pediatric Intensive Care Unit (PICU) of Ghent University Hospital who are receiving intravenous therapy with piperacillin-tazobactam, meropenem, or amoxicillin-clavulanic acid for known or suspected severe infection/sepsis. All included patients are under continuous analgosedation and mechanical ventilation at the time of microdialysis catheter placement and have established intra-arterial or intravenous access for routine blood sampling.
- Ages
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1 month to 15 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ghent University Hospital
RECRUITINGGhent, 9000, Belgium
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