Actively Recruiting

Phase Not Applicable
Age: 0 - 15Years
All Genders
ID06426836

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

Age: 0 - 15Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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 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

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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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