Individualised amoxicillin-clavulanate dosing recommendations for critically ill children with augmented clearance after cardiac surgery.
Evelyn Dhont, Joseph F Standing, Emma Beel...
https://pubmed.ncbi.nlm.nih.gov/40239747Actively Recruiting
Age: 1Day - 16Years
All Genders
ID02456974
Antibiotic Dosing in Pediatric Intensive Care
Led by University Hospital, Ghent · Updated on 2026-01-16
640
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
U
University Hospital, Antwerp
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research focuses on understanding how antibiotics behave in the bodies of critically ill newborns, infants, and children aged from 1.8 kilograms up to 15 years who are admitted to pediatric intensive care. The study aims to evaluate if current dosing regimens achieve effective blood concentrations of antibiotics such as amoxicillin-clavulanate, piperacillin-tazobactam, vancomycin, teicoplanin, meropenem, ciprofloxacin, and amikacin. This information is important for guiding safe and effective antibiotic use in young patients under intensive care. Participants receive routine clinical care including treatment with one of the listed antibiotics administered through intermittent or continuous infusion. Blood, and in some cases urine, samples are collected from existing arterial or intravenous lines to monitor antibiotic levels. These procedures are performed during usual care without additional experimental treatments. During the study, patients will have their first-dose and steady-state blood concentrations of antibiotics measured and compared with targets for maximum antimicrobial activity. The study also collects urine samples for some antibiotics. Researchers aim to understand how well current antibiotic doses reach desired levels to guide future dosing strategies. Participation involves blood and urine sampling while receiving standard care, with safety monitored throughout the study period, which is expected to last approximately two years.
CONDITIONS
Brief Title
Antibiotic Dosing in Pediatric Intensive Care
Who Can Participate
Age: 1Day - 16Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients admitted to the pediatric intensive care unit
- Patient age/weight between 1.8 kilograms and 15 years
- Patient receiving antibiotic treatment with piperacillin-tazobactam, amoxicillin-clavulanate, vancomycin, teicoplanin, meropenem, ciprofloxacin, or amikacin via intermittent or continuous infusion according to institutional guidelines
- Intra-arterial or intravenous access other than the drug infusion line available for blood sampling; arterial line preferred
You will not qualify if you...
- No catheter in place for blood sampling
- Absence of parental or patient consent
- Known hypersensitivity to beta-lactam antibiotics, glycopeptides, fluoroquinolones, or aminoglycosides
- Use of extracorporeal circuits such as haemodialysis, ECMO, or peritoneal dialysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 2 years
Participants who undergo routine care with specified antibiotics are observed and have blood and urine samples collected as part of clinical care.
Sampling occurs during routine clinical care visits depending on antibiotic treatment
Trial Site Locations
Total: 1 location
1
Ghent University Hospital, Hospital Pharmacy
Ghent, Belgium, 9000
Actively Recruiting
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Research Team
P
Pieter De Cock, PharmD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
7
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Published Research Related To This Trial
Suboptimal Beta-Lactam Therapy in Critically Ill Children: Risk Factors and Outcome.
Tatjana Van Der Heggen, Evelyn Dhont, Jef Willems...
https://pubmed.ncbi.nlm.nih.gov/35426861Population Pharmacokinetics of Unbound and Total Teicoplanin in Critically Ill Pediatric Patients.
L B S Aulin, P De Paepe, E Dhont...
https://pubmed.ncbi.nlm.nih.gov/33030704Impact of vancomycin protein binding on target attainment in critically ill children: back to the drawing board?
Pieter A J G De Cock, Sarah Desmet, Annick De Jaeger...
https://pubmed.ncbi.nlm.nih.gov/27999035Augmented renal clearance implies a need for increased amoxicillin-clavulanic acid dosing in critically ill children.
Pieter A J G De Cock, Joseph F Standing, Charlotte I S Barker...
https://pubmed.ncbi.nlm.nih.gov/26349821