Precision Dosing of Beta-lactam Antibiotics in Critically Ill Children
NCT ID: NCT06929702
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
58 participants
INTERVENTIONAL
2025-04-22
2027-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Standard of Care beta-lactam treatment
Beta-lactam standard-of-care dosing regimen, as currently used at participating wards, during 28 day study period
Beta-lactam antibiotic
amoxicillin-clavulanic acid, piperacillin-tazobactam, meropenem treatment
Beta-lactam model-informed precision dosing
fT\>MIC-based model-informed precision dosing of beta-lactam antibiotics using a dosing calculator during 28 day study period.
Beta-lactam antibiotic
amoxicillin-clavulanic acid, piperacillin-tazobactam, meropenem treatment
Beta-lactam model-informed precision dosing
A dosing calculator is used for the prediction of starting doses (a priori dose predictions) and follow-up doses (a posteriori calculations), using a target 100% fT\>MIC.
Interventions
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Beta-lactam antibiotic
amoxicillin-clavulanic acid, piperacillin-tazobactam, meropenem treatment
Beta-lactam model-informed precision dosing
A dosing calculator is used for the prediction of starting doses (a priori dose predictions) and follow-up doses (a posteriori calculations), using a target 100% fT\>MIC.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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).
0 Years
18 Years
ALL
No
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Evelyn Dhont, Dr.
Role: PRINCIPAL_INVESTIGATOR
Ghent University Hospital, Princess Elisabeth Children's Hospital
Locations
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Ghent University Hospital
Ghent, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-516447-12-00
Identifier Type: CTIS
Identifier Source: secondary_id
ONZ-2024-0295
Identifier Type: -
Identifier Source: org_study_id
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