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Набор скоро начнётся NCT06210542

Precise Treatment of Ceftazidime-Avibactam in Patients With CRO Infections Under the Guidance of TDM and PPK Model

— Наблюдательное ECMO Carbapenem-Resistant Enterobacteriaceae Infection

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: ceftazidime avibactam.
Кому может быть актуально
Состояния в реестре: ECMO, Carbapenem-Resistant Enterobacteriaceae Infection. Базовые параметры: 18 лет — 85 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this study is to evaluate the efficacy and safety of ceftazidime-avibactam(CAZ-AVI) in the treatment of critically ill patients with carbapenem-resistant organisms(CRO) infections (including dialysis patients and extracorporeal membrane oxygenation(ECMO) patients).

Подробное описание

This is a prospective observational multicentre study. The study is to obtain the real world data of the efficacy and safety of ceftazidime-avibactam(CAZ-AVI) in the treatment of critically ill patients with carbapenem-resistant organisms(CRO) infections (including dialysis patients and extracorporeal membrane oxygenation(ECMO) patients) by using therapeutic drug monitoring(TDM). A population-pharmacokinetic(PPK) model of CAZ-AV in these patients will be established in this study. The main question it aims to answer is the clinical success rate and microbiological success rate of CAZ-AVI based regimen in the treatment of critically ill patients with CRO infections. According to the clinical practice (symptoms, signs, imaging, culture and drug sensitivity, etc.), the doctor determines the combined regimen of CAZ-AVI, and the combined drugs are used routinely according to their instructions or clinical diagnosis and treatment.

Вмешательства

  • Препарат ceftazidime avibactam
    Routine treatment dose for patients: the recommended intravenous dose for patients with creatinine clearance rate (eCrCL) \> 50ml/min was 2.5g (2g/0.5g), once every 8 hours, and the infusion time was 2 hours. Patients with renal injury adjust the dosage according to eCrCL

Первичные конечные точки

  • Clinical success rate at the end of treatment and/or the time transfer out of ICU [Срок оценки: the end of treatment or the time transfer out of ICU,up to 1 year.]
  • Microbiologic success rate at the end of treatment and/or the time transfer out of ICU [Срок оценки: the end of treatment or the time transfer out of ICU,up to 1 year.]
Вторичные конечные точки (7)
  • All-cause mortality on day 28 after drug initiation [Срок оценки: 28 days from drug initiation]
  • Infection-related mortality during hospitalization in ICU [Срок оценки: the end of treatment or the time transfer out of ICU,up to 1 year.]
  • All-cause mortality on 90 days after drug initiation [Срок оценки: 90 days from drug initiation]
  • Recurrence rate of infection on day 28 after starting medication [Срок оценки: 28 days from drug initiation]
  • Length of ICU Stay [Срок оценки: the end of treatment or the time transfer out of ICU,up to 1 year.]
  • Length of Hospital Stay (LOS) [Срок оценки: the end of treatment or the time transfer out of ICU,up to 1 year.]
  • Time from ceftazidime-avibactam treatment initiation to symptom improvement [Срок оценки: the end of treatment or the time transfer out of ICU,up to 1 year.]

Критерии участия

Критерии включения

  • 18-85 years old.
  • Hospitalized participants in ICU who did not receive Ceftazidime Avibactam treatment within 15 days before joining the study.
  • Participants with severe infection (refer to the 2022 sepsis3.0 guidelines for the definition of severe infection).
  • at least one carbapenem-resistant Gram-negative pathogen (including but not limited to carbapenem-resistant Enterobacteriaceae and / or Pseudomonas aeruginosa) was confirmed by bacterial culture in the primary infection site samples.
  • sufficient respiratory secretions, blood and peritoneal effusion can be obtained within 48 hours before the first administration for bacterial culture and drug sensitivity test.
  • intravenous injection of Ceftazidime Avibactam for more than 72 hours.
  • understand compliance with research procedures and methods, voluntarily participate in this study, and sign informed consent in writing.

Критерии исключения

  • Participants are less than 18.
  • Death within 72 hours after the start of treatment.
  • Known resistance to β-lactam antibacterial drugs including cephalosporins, cephalosporin compound preparations containing β-lactamase inhibitors, or Those with a history of allergies to ceftazidime avibactam sodium for injection and its excipients.
  • No indication for treatment with ceftazidime avibactam.
  • Pregnant and lactating women.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06210542 · LPan20230579

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗