Understanding antibiotic dosing in critically ill children
Antibiotic Dosing in Pediatric Intensive Care
This study is trying to find the best antibiotic doses for critically ill children in the hospital to make sure they get effective treatment with fewer side effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 640 (estimated) |
| Ages | 1 Day to 16 Years |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent) |
| Trial ID | NCT02456974 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the pharmacokinetics of various antibiotics in critically ill neonates, infants, and children admitted to the pediatric intensive care unit. It involves blood sampling from patients receiving antibiotics such as amoxicillin-clavulanate, piperacillin-tazobactam, vancomycin, teicoplanin, and meropenem as part of their routine clinical care. The goal is to gather data that can help optimize antibiotic dosing in this vulnerable population, ensuring effective treatment while minimizing potential side effects.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients aged between 1.8 kg and 15 years who are receiving specific antibiotic treatments in a pediatric intensive care setting.
Not a fit: Patients who do not have a catheter in place for blood sampling or have known hypersensitivity to the antibiotics being studied may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved antibiotic dosing strategies that enhance treatment outcomes for critically ill pediatric patients.
How similar studies have performed: Other studies have explored antibiotic pharmacokinetics in pediatric populations, indicating potential for success in optimizing treatment approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients admitted to the pediatric intensive care unit * patient age/weight : 1,8 kg-15 years * patient receiving antibiotic treatment (piperacillin-tazobactam, amoxicillin-clavulanate, vancomycin, teicoplanin, meropenem, ciprofloxacin, amikacin) via intermittent infusion regimen or continuous infusion according to institutional treatment guidelines * intra-arterial or intravenous access other than the drug infusion line available for blood sampling (arterial line is preferred) Exclusion Criteria: * no catheter in place for blood sampling * absence of parental/patient consent * known hypersensitivity to beta-lactam antibiotics, glycopeptides, fluoroquinolones, aminoglycosides * extracorporeal circuit (haemodialysis, ECMO, peritoneal dialysis )
Where this trial is running
Ghent
- Ghent University Hospital, Hospital Pharmacy — Ghent, Belgium (Recruiting)
Study contacts
- Principal investigator: Pieter De Cock — 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.