Status:
NOT_YET_RECRUITING
Precision Dosing of Beta-lactam Antibiotics in Critically Ill Children
Lead Sponsor:
University Hospital, Ghent
Conditions:
Amoxicillin-clavulanate
Piperacillin-tazobactam
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE4
Brief Summary
The overall objective of this study is to investigate the impact of early model-informed precision dosing (MIPD) on target attainment of three beta-lactam antibiotics (amoxicillin-clavulanic acid, pip...
Eligibility Criteria
Inclusion
- Subject aged between 0 - 17 years 10 months.
- Subject admitted to a participating ward unit (Neonatal Intensive Care Unit, Pediatric Intensive Care Unit, Pediatric Hematology-Oncology unit).
- Strongly suspected or confirmed systemic infection.
- Subject planned to start on intravenous amoxicillin-clavulanic acid, piperacillin-tazobactam or meropenem treatment at least aimed for a minimum duration of two days at time of inclusion. If the subject was previously treated with the same beta-lactam, the minimum interval to the previous beta-lactam treatment episode is
- 40 hours for amoxicillin-clavulanic acid (based on elimination half-life)
- 8 hours for piperacillin-tazobactam and meropenem (based on elimination half-life) Subject planned to start on intravenous amoxicillin (without clavulanic acid) will not be included.
- Informed consent/assent signed by parents or legal representatives of the subject.
- Not previously enrolled in this trial.
Exclusion
- Subject with serum creatinine level ≥ 2 mg/L at inclusion.
- Subject receiving (or planned to receive) haemofiltration, extracorporeal membrane oxygenation, hemodialysis or peritoneal dialysis, molecular adsorbent recirculating system or any other exchange technique.
- Subject receiving (or planned to receive) body cooling.
- Subject death is deemed imminent and inevitable.
- Reporting of first dosing advice (based on blood sampling) is not possible within 28 hours (\*) after start treatment.
- The subject is known or suspected to be pregnant.
- The subject has a known allergy to the specific beta-lactam antibiotic.
- (\*) The first (a posteriori) dose calculation and dose adjustment if necessary, is performed within a maximum timeframe of 28 hours after start of treatment (i.e. maximum timeframe to first dose adjustment).
Key Trial Info
Start Date :
April 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT06929702
Start Date
April 22 2025
End Date
October 1 2027
Last Update
April 16 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ghent University Hospital
Ghent, Belgium, 9000