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Идёт набор NCT06426836

Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation (PADECMO)

Без фазы С лечением Pharmacokinetics Amoxicillin-clavulanate Piperacillin-tazobactam Meropenem

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Amoxicillin-clavulanate, Piperacillin-tazobactam, Meropenem, Cefazolin.
Кому может быть актуально
Состояния в реестре: Pharmacokinetics, Amoxicillin-clavulanate, Piperacillin-tazobactam, Meropenem. Базовые параметры: до 15 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бельгия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation

Обзор

Pharmacokinetics of antibiotics in critically ill neonates, infants and children on extracorporeal membrane oxygenation (ECMO).

Подробное описание

The study will investigate whether - with the current dosing regimens of meropenem, piperacillin-tazobactam, amoxicillin-clavulanate, cephazolin, vancomycin, amikacin, teicoplanin and ciprofloxacin - pharmacodynamic targets are attained in a national multicentric clinical setting in pediatric patients on ECMO.

Вмешательства

  • Другое Amoxicillin-clavulanate
    blood sampling in patients receiving amoxicillin-clavulanate as part of routine clinical care
  • Другое Piperacillin-tazobactam
    blood sampling in patients receiving piperacillin-tazobactam as part of routine clinical care.
  • Другое Meropenem
    blood sampling in patients receiving meropenem as part of routine clinical care.
  • Другое Cefazolin
    blood sampling in patients receiving cefazolin as part of routine clinical care.
  • Другое Vancomycin
    blood sampling in patients receiving vancomycin as part of routine clinical care.
  • Другое Teicoplanin
    blood sampling in patients receiving teicoplanin as part of routine clinical care.
  • Другое Ciprofloxacin
    blood sampling and urine sampling in patients receiving ciprofloxacin as part of routine clinical care.
  • Другое Amikacin
    blood sampling in patients receiving amikacin as part of routine clinical care.

Первичные конечные точки

  • Amoxicillin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism [Срок оценки: up to 1 month]
  • Cefazolin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism [Срок оценки: up to 1 month]
  • Meropenem: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism [Срок оценки: up to 1 month]
  • Piperacillin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism [Срок оценки: up to 1 month]
  • Amoxicillin, piperacillin, meropenem, cefazolin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism [Срок оценки: up to 1 month]
  • Cefazolin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism [Срок оценки: up to 1 month]
  • Meropenem: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism [Срок оценки: up to 1 month]
  • Piperacillin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism [Срок оценки: up to 1 month]
  • Ciprofloxacin: probability of target attainment with the target being the free Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration ratio (fAUC/MIC) [Срок оценки: up to 1 month]
  • Vancomycin: probability of target attainment with the target being the Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration (AUC/MIC) [Срок оценки: up to 1 month]
Вторичные конечные точки (11)
  • Risk factors for underdosing during extracorporeal membrane oxygenation for beta-lactam antibiotics [Срок оценки: up to 1 month]
  • Risk factors for underdosing during extracorporeal membrane oxygenation for ciprofloxacin [Срок оценки: up to 1 month]
  • Risk factors for under-and overdosing during extracorporeal membrane oxygenation for vancomycin [Срок оценки: up to 1 month]
  • Risk factors for underdosing during extracorporeal membrane oxygenation for teicoplanin [Срок оценки: up to 1 month]
  • Risk factors for under-and overdosing during extracorporeal membrane oxygenation for amikacin [Срок оценки: up to 1 month]
  • Beta-lactam antibiotics (amoxicillin, piperacillin, meropenem, cefazolin): probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) [Срок оценки: up to 1 month]
  • Ciprofloxacin: probability of target attainment with the target being the free Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration ratio (fAUC/MIC) [Срок оценки: up to 1 month]
  • Vancomycin: probability of target attainment with the target being the Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration (AUC/MIC) [Срок оценки: up to 1 month]
  • Teicoplanin: probability of target attainment with the target being a mimimal trough concentration [Срок оценки: up to 1 month]
  • Amikacin: probability of target attainment with the target being a peak concentration over Minimal Inhibitory Concentration ratio (peak/MIC) [Срок оценки: up to 1 month]
  • Amikacin: probability of toxicity threshold attainment with a target being a minimal trough concentration [Срок оценки: up to 1 month]

Критерии участия

Критерии включения

  • patients admitted to the pediatric intensive care unit or cardiac intensive care unit
  • patient age : 1,8 kg-15 years
  • patient receiving antibiotic treatment (piperacillin-tazobactam, meropenem, amoxicillin-clavulanate, cephazolin, vancomycin, teicoplanin, ciprofloxacin, amikacin)
  • intra-arterial or intravenous access other than the drug infusion line available for blood sampling (arterial line is preferred)
  • extracorporeal membrane oxygenation circuit

Критерии исключения

  • no catheter in place for blood sampling
  • absence of parental/patient consent
  • known hypersensitivity to beta-lactam antibiotics and ciprofloxacin

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Бельгия · 3 центра
  • Queen Fabiola Children's University Hospital — Brussels
  • University Hospital — Ghent
  • Universitair hospital — Leuven

Идентификаторы

NCT: NCT06426836 · EC 2015/0529

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗