An observational study in Pediatric Critical Illness and Critical Illness, sponsored by University Hospital, Ghent. Recruiting at 1 site in Belgium. Open to participants aged 1 Month to 15 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by University Hospital, Ghent · Observational
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:
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:
Pathophysiological alterations during critical illness, such as severe sepsis and septic shock, frequently alter the pharmacokinetics (PK) and pharmacodynamics (PD) of beta-lactam antibiotics. In pediatric critical care, these changes are further complicated by ongoing physiological growth and developmental changes in drug absorption, distribution, metabolism, and excretion. Although research in critically ill children has demonstrated that standard intravenous dosing regimens often fail to achieve target plasma concentrations, plasma levels alone do not necessarily reflect drug disposition at the actual site of infection. For extracellular pathogens, the target site of infection corresponds to the interstitial fluid (ISF) of tissues. Studies in adult septic populations suggest that subtherapeutic antibiotic concentrations in ISF may contribute to treatment failure, even when total plasma concentrations appear adequate. Data regarding antibiotic tissue disposition in pediatric intensive care unit (PICU) patients remain extremely limited. This monocentric, prospective, observational pharmacokinetic study utilizes in vivo microdialysis to directly quantify unbound tissue concentrations of three hydrophilic beta-lactam antibiotics-piperacillin-tazobactam, meropenem, and amoxicillin-clavulanic acid-in the ISF of skeletal muscle in critically ill pediatric patients.
The study will be conducted as follows:
Perfusion and Calibration: The probe is continuously perfused with 0.9% physiological saline at a fixed flow rate via microinfusion precision pumps. After an equilibration period, in vivo probe recovery is determined using both retrodialysis and internal standard methods:
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's planned enrollment of 60 is below the median of 140 across 814 observational studies indexed under Critical Illness.
Browse Critical Illness studies →University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Presence of coagulopathy and/or thrombocytopenia:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Critically ill pediatric patients (N=60 total) admitted to the Pediatric Intensive Care Unit (PICU) with continuous analgosedation who are prescribed routine intravenous therapy with one of three beta-lactam antibiotics (piperacillin-tazobactam, meropenem, or amoxicillin-clavulanic acid) as part of standard medical care. All participants undergo skeletal muscle microdialysis and paired blood sampling.
Other: Pharmacokinetic sampling (Microdialysis and blood sampling)
Intervention Description: Insertion of a 63 Microdialysis Catheter (M Dialysis AB; 20 kDa cutoff, 10 mm membrane) into the vastus lateralis muscle to measure unbound interstitial fluid antibiotic concentrations (calibrated using retrodialysis and an internal standard), combined with paired blood sampling via existing arterial/venous access to determine total and unbound plasma concentrations.
Tissue-to-plasma AUC ratio of beta-lactam antibiotics
Ratio of the area under the concentration-time curve (AUC) of unbound beta-lactam antibiotic (piperacillin-tazobactam, meropenem, or amoxicillin-clavulanic acid) in skeletal muscle interstitial fluid (measured via microdialysis) to the AUC of total/unbound antibiotic in plasma. This evaluates the extent of tissue penetration.
Time frame: Up to 48 hours (measured over two separate dosing intervals)
Pharmacokinetic/pharmacodynamic (PK/PD) target attainment in plasma and tissue
Percentage of time during the dosing interval that unbound plasma and tissue antibiotic concentration remains above the Minimum Inhibitory Concentration (%fT\>MIC) of the target micro-organism in interstitial fluid.
Time frame: Up to 48 hours (across sampled dosing intervals)
Started Oct 2021 (actual). Primary completion is estimated for Dec 2026, 62 months after the start.
Of 439 non-industry observational studies under Critical Illness, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 62 months is above that.
Counting every sponsor, half of 442 studies reached it within 23 months; a quarter within 12 and three quarters within 46.
Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
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