Actively Recruiting
Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation
Led by University Hospital, Ghent · Updated on 2026-01-16
300
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how antibiotics behave in critically ill newborns, infants, and children who are on extracorporeal membrane oxygenation (ECMO), a life-support technique. The goal is to understand if current dosing of several antibiotics used in pediatric patients on ECMO meets the desired drug concentration targets to fight infections effectively in a national multicenter setting. The study involves patients receiving one of these antibiotics as part of their regular care: meropenem, piperacillin-tazobactam, amoxicillin-clavulanate, cefazolin, vancomycin, amikacin, teicoplanin, or ciprofloxacin. Blood samples, and in the case of ciprofloxacin also urine samples, will be taken during routine care to monitor antibiotic levels and evaluate pharmacodynamic targets. The study is non-randomized and includes multiple groups depending on the antibiotic received. Participants are pediatric patients up to 15 years old admitted to intensive care units and receiving ECMO. The study collects samples up to one month to measure how well the antibiotic concentrations reach target levels associated with fighting infection. Researchers will assess risks of underdosing or overdosing and monitor drug concentration patterns. The study is sponsored by University Hospital, Ghent, and will continue monitoring until 2026.
CONDITIONS
Brief Title
Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation (PADECMO)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients admitted to the pediatric intensive care unit or cardiac intensive care unit
- Patient age between 1.8 kilograms and 15 years
- Patient receiving antibiotic treatment with piperacillin-tazobactam, meropenem, amoxicillin-clavulanate, cefazolin, vancomycin, teicoplanin, ciprofloxacin, or amikacin
- Intra-arterial or intravenous access other than the drug infusion line available for blood sampling (arterial line preferred)
- Extracorporeal membrane oxygenation (ECMO) circuit present
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 or ciprofloxacin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 month
Participants who undergo routine antibiotic treatment while on extracorporeal membrane oxygenation (ECMO) are observed through blood and urine sampling to assess drug concentration targets.
Blood and urine sampling during routine clinical care visits
Trial Site Locations
Total: 3 locations
1
Queen Fabiola Children's University Hospital
Brussels, Brussels Capital, Belgium, 1020
Actively Recruiting
2
University Hospital
Ghent, Belgium, 9000
Actively Recruiting
3
Universitair hospital
Leuven, Belgium, 3000
Actively Recruiting
Research Team
P
Pieter De Cock, PharmD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
8
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