Precision Dosing of Beta-lactam Antibiotics in Critically Ill Children

Официальное название

Early Model-Informed Precision Dosing of Beta-lactam Antibiotics in Critically Ill Children: Big Solution for Small People?

Обзор

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.

Вмешательства

• Препарат Beta-lactam antibiotic
  amoxicillin-clavulanic acid, piperacillin-tazobactam, meropenem treatment
• Устройство 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.

Первичные конечные точки

• Proportion of subjects reaching the therapeutic target 100% fT>MIC [Срок оценки: At 48 hours after start of beta-lactam treatment]

Вторичные конечные точки (3)

• Proportion of subjects reaching the therapeutic target 100% fT>MIC [Срок оценки: At 120 hours after start of beta-lactam treatment]
• Proportion of subjects reaching the therapeutic target 100% fT>MIC [Срок оценки: Within the interval 48 to 72 hours after start of beta-treatment]
• Hospital length-of-stay [Срок оценки: From date of randomization until date of hospital discharge, with a maximum of 28 days.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• Ghent University Hospital — Ghent

Идентификаторы

NCT: NCT06929702 · ONZ-2024-0295 · 2024-516447-12-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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