Precision Dosing of Beta-lactam Antibiotics in Critically Ill Children (MOMENTUM)

Ghent University Hospital (UZ)

Status and phase: Not yet enrolling; Phase 4

Conditions: Meropenem; Piperacillin-tazobactam; Amoxicillin-clavulanate

Treatments: Drug: Beta-lactam antibiotic; Device: Beta-lactam model-informed precision dosing

Study type: Interventional

Funder types: Other

Identifiers

NCT06929702

2024-516447-12-00 (EU Trial (CTIS) Number)

ONZ-2024-0295

Details and patient eligibility

About

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, piperacillin-tazobactam and meropenem) in critically ill children. This evaluation includes a comparison with the more standard approach on clinical and patient-oriented measures.

Enrollment: 58 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups

Standard of Care beta-lactam treatment

Active Comparator group

Description:

Beta-lactam standard-of-care dosing regimen, as currently used at participating wards, during 28 day study period

Treatment:

Drug: Beta-lactam antibiotic

Beta-lactam model-informed precision dosing

Experimental group

Description:

fT\>MIC-based model-informed precision dosing of beta-lactam antibiotics using a dosing calculator during 28 day study period.

Treatment:

Device: Beta-lactam model-informed precision dosing

Drug: Beta-lactam antibiotic