Investigating antibiotic dosing in critically ill children on ECMO
Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation
This study is testing if the current antibiotic doses are strong enough to help critically ill children on ECMO get better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | N/A to 15 Years |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 3 sites (Brussels, Brussels Capital and 2 other locations) |
| Trial ID | NCT06426836 on ClinicalTrials.gov |
What this trial studies
This study examines the pharmacokinetics of various antibiotics in critically ill pediatric patients who are on extracorporeal membrane oxygenation (ECMO). It aims to determine if current dosing regimens for antibiotics such as meropenem, piperacillin-tazobactam, and amoxicillin-clavulanate achieve the necessary pharmacodynamic targets. The research will be conducted in a multicentric clinical setting across several pediatric intensive care units. Blood samples will be collected from patients receiving these antibiotics to assess their effectiveness.
Who should consider this trial
Good fit: Ideal candidates include neonates, infants, and children aged 1.8 kg to 15 years who are on ECMO and receiving specific antibiotic treatments.
Not a fit: Patients without a catheter for blood sampling or those with known hypersensitivity to beta-lactam antibiotics and ciprofloxacin may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could optimize antibiotic dosing in critically ill children, improving treatment outcomes.
How similar studies have performed: Other studies have explored antibiotic dosing in pediatric populations, but this specific approach in ECMO patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients admitted to the pediatric intensive care unit or cardiac intensive care unit * patient age : 1,8 kg-15 years * patient receiving antibiotic treatment (piperacillin-tazobactam, meropenem, amoxicillin-clavulanate, cephazolin, vancomycin, teicoplanin, ciprofloxacin, amikacin) * intra-arterial or intravenous access other than the drug infusion line available for blood sampling (arterial line is preferred) * extracorporeal membrane oxygenation circuit Exclusion Criteria: * no catheter in place for blood sampling * absence of parental/patient consent * known hypersensitivity to beta-lactam antibiotics and ciprofloxacin
Where this trial is running
Brussels, Brussels Capital and 2 other locations
- Queen Fabiola Children's University Hospital — Brussels, Brussels Capital, Belgium (Recruiting)
- University Hospital — Ghent, Belgium (Recruiting)
- Universitair hospital — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Annick de Jaeger, MD — University Hospital, Ghent
- Study coordinator: Pieter De Cock, PharmD
- Email: pieter.decock@uzgent.be
- Phone: +32 9 332 29 69
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.