Precision dosing of beta-lactam antibiotics in critically ill children
Official title: Early Model-Informed Precision Dosing of Beta-lactam Antibiotics in Critically Ill Children: Big Solution for Small People?
Run by University Hospital, Ghent · NCT06929702 · Data updated 2026-11-12
This study tests whether using model-informed precision dosing can help critically ill kids reach target antibiotic levels earlier when treated with amoxicillin-clavulanate, piperacillin-tazobactam, or meropenem.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 0 Years to 18 Years |
| Sex | All |
| Enrollment | 58 (estimated) |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent) |
| Status | Recruiting |
| Started | July 9, 2025 |
| Main results expected | October 1, 2027 |
| Study ends | October 1, 2027 |
| Registry record updated | September 17, 2026 |
| Trial ID | NCT06929702 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 0 to 17 years 10 months with suspected or confirmed systemic infection, admitted to NICU, PICU, or pediatric hematology-oncology units, and planned IV treatment with amoxicillin-clavulanic acid, piperacillin-tazobactam, or meropenem for at least two days.
✕Probably not a fit
Patients not expected to benefit include those not receiving one of the target antibiotics or not meeting the timing/eligibility criteria.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial evaluates the impact of early model-informed precision dosing (MIPD) on achieving target drug exposure for three beta-lactam antibiotics in critically ill pediatric patients. It compares MIPD-guided dosing with standard dosing to see effects on clinical and patient-oriented outcomes. Eligible participants are children from birth to 17 years 10 months with suspected or confirmed severe infection and planned IV therapy for at least two days. The study is conducted at Ghent University Hospital, led by University Hospital Ghent, with no listed collaborators. Interventions include beta-lactam antibiotics and a model-informed precision dosing approach.
Why it matters
Potential benefit: If successful, MIPD could improve antibiotic target attainment and potentially patient outcomes in critically ill children.
How similar studies have gone: Prior work in adults and pediatrics suggests model-informed dosing can improve target attainment, but pediatric data in this exact setting are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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).
Where it's running
-
Ghent University Hospital
Ghent, Belgium Recruiting
Study contacts
- Principal investigator: Evelyn Dhont, Dr. — Ghent University Hospital, Princess Elisabeth Children's Hospital
- Study coordinator: Pieter De Cock, Prof.
- Email: pieter.decock@uzgent.be
- Phone: +32 9 332 29 69
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Investigating antibiotic dosing in critically ill children on ECMO
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-
Understanding antibiotic dosing in critically ill children
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.
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Subcutaneous versus IV piperacillin/tazobactam for adults with serious bacterial infections
This study will try whether giving piperacillin/tazobactam under the skin (continuous subcutaneous infusion) produces similar drug levels and safety as the standard IV continuous infusion for adults being treated for serious bacterial infections.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.