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Идёт набор NCT05783661

Trial Comparing Conventional Antibiotic Strategies Versus Regimens Guided by Epidemiological Surveillance in Infected Patients With Cirrhosis (SURVIC_STUDY)

Фаза IV С лечением Decompensated Cirrhosis Bacterial Infections

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: Conventional antibiotic strategies, Regimens guided by epidemiological surveillance.
Кому может быть актуально
Состояния в реестре: Decompensated Cirrhosis, Bacterial Infections. Базовые параметры: от 18 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
Испания
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

Randomized Controlled Trial Comparing Conventional Antibiotic Strategies Versus Regimens Guided by Epidemiological Surveillance in Infected Patients With Cirrhosis

Обзор

Study to comparing conventrional antibiotic strategies versus regimens guided by epidemiological surveillance in infected patients with cirrhosis.

Вмешательства

  • Другое Conventional antibiotic strategies
    Treatment according to the local guidelines of the Hospital Clinic de Barcelona.
  • Другое Regimens guided by epidemiological surveillance
    Treatment according to the local guidelines of the Hospital Clinic de Barcelona guided by colonization/epidemiological surveillance.

Первичные конечные точки

  • Probability/rate of participants of developing antibiotic resistance in both treatment arms at 28 days. [Срок оценки: 28 days]
Вторичные конечные точки (12)
  • Probability of antibiotic resistance development during hospitalization in both treatment arms. [Срок оценки: During hospitalization (until discharge), assessed up to day 28.]
  • Rate of antibiotic resistance development during hospitalization in both treatment arms. [Срок оценки: During hospitalization (until discharge), assessed up to day 28.]
  • Rate of MDRO colonization during hospitalization and at 28 days in both treatment arms. [Срок оценки: During hospitalization (until discharge), assessed up to day 28 and at 28 days.]
  • Probability of MDRO colonization during hospitalization and at 28 days in both treatment arms. [Срок оценки: During hospitalization (until discharge), assessed up to day 28 and at 28 days.]
  • Rate of MDRO infection during hospitalization and at 28 days in both treatment arms. [Срок оценки: During hospitalization (until discharge), assessed up to day 28 and at 28 days.]
  • Probability of MDRO infection during hospitalization and at 28 days in both treatment arms. [Срок оценки: During hospitalization (until discharge), assessed up to day 28 and at 28 days.]
  • Infection resolution rate with initial and final strategies in both treatment arms. [Срок оценки: Through study completion, an average of 28 days]
  • Evolution of score ACLF (Acute-on-Chronic Liver Failure) in both treatment arms. [Срок оценки: Through study completion, an average of 28 days]
  • Evolution of score MELD (Model For End-Stage Liver Disease) in both treatment arms. [Срок оценки: Through study completion, an average of 28 days]
  • Evolution of score Child-Pugh in both treatment arms. [Срок оценки: Through study completion, an average of 28 days]
  • Evolution of score CLIF-OF (Liver Failure Consortium - Organ Failure) in both treatment arms. [Срок оценки: Through study completion, an average of 28 days]
  • Evolution of score CLIF-C AD (Chronic Liver Failure Consortium - non-ACLF patients with Acute Decompensation) in both treatment arms. [Срок оценки: Through study completion, an average of 28 days]

Критерии участия

Критерии включения

  • Cirrhotic patients with acute decompensation aged ≥18 years.
  • Proven or suspected bacterial infection requiring antibiotic therapy (diagnosis will be established according to local guidelines, Appendix 1).
  • Signed informed consent or consent given by their legal representatives or close relatives.

Критерии исключения

  • Bacterial infection lasting for > 48 hours.
  • Infection in a critically ill cirrhotic patient (ICU admission). In this population, epidemiological surveillance is standard clinical practice.
  • MDR colonization or infection in the last month.
  • Evidence of current locally advanced or metastatic malignancy (patients with hepatocellular carcinoma within the Milan criteria and non-melanocytic skin cancer can be included).
  • Pregnant and/or breast-feeding woman.
  • Patients who cannot provide prior informed consent and when there is documented evidence that the patient has no legal surrogate decision-maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent.

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
Открытое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Eva Bonfill — Barcelona

Идентификаторы

NCT: NCT05783661 · 2022-001858-33

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗