A Study on the Combination Therapy of Eravacycline for Treating Carbapenem-Resistant Acinetobacter Baumannii Pneumonia

Обзор

This study intends to evaluate the efficacy and safety of eravacycline-based combination therapy in real words for Chinese patients with CRAB pneumonia, providing data reference for clinical treatment of CRAB pneumonia.

Подробное описание

This study aims to include 50 patients proven or suspected diagnosed carbapenem-resistant Acinetobacter baumannii pneumonia at Peking University Third Hospital. The physician determines to use a combination regimen of eravacycline, including sulbactam or compound preparations containing sulbactam, polymyxin B, and β-lactam antibiotics, is considered. The clinical response rate at the end of treatment is the primary endpoint of the study; the secondary endpoints include the clearance rate of carbapenem-resistant Acinetobacter baumannii, the incidence of adverse events, and the all-cause mortality rate within 28 days.

Вмешательства

• Препарат Eravacycline combination therapy group
  Physicians determine the combination regimen of eravacycline, which may include sulbactam or compound preparations containing sulbactam, polymyxin B, beta-lactam antibiotics, etc., based on the pathogen identification and susceptibility results, and the China Guidelines for Diagnosis, Treatment, and Prevention of Infections Caused by Carbapenem-Resistant Gram-Negative Bacteria." The combined drugs are used according to their instructions for use or clinical practice guidelines.

Первичные конечные точки

• clinical efficacy at the end of treatment [Срок оценки: up to the end of treatment, up to 4 weeks(estimation)]

Вторичные конечные точки (3)

• Incidence Rate of Adverse Event [Срок оценки: up to the end of treatment, up to 4 weeks(estimation)]
• The microbiological clearance rate [Срок оценки: up to the end of treatment, up to 4 weeks(estimation)]
• The all cause mortality rate [Срок оценки: 28 days]

Критерии участия

Критерии включения

• Aged 18 years or older.
• Voluntarily participating in this study and signing an informed consent form. If the subject is unable to read and/or sign the informed consent form due to lack of capacity or other reasons, the informed process and the informed consent form must be signed by their legal guardian.
• Patients with clinical manifestations and imaging results consistent with bacterial pneumonia, and who are expected to benefit from antimicrobial treatment. Suspected carbapenem-resistant Acinetobacter baumannii infection or Acinetobacter baumannii detected in two consecutive sputum cultures (at least one of which must be from bronchoalveolar lavage or endotracheal aspirate), with resistance to carbapenems.
• Patients who have been treated with eravacycline for at least 3 days.

Критерии исключения

• The investigator believes that there are any medical history, current condition, treatment, abnormal laboratory test results, or other situations that may affect the trial results, interrupt the trial process (or the subject cannot complete all trial requirements, operations, and visits), or increase the risk to the subject from receiving the trial medication, including patients with terminal illness, or evidence of an immediately life-threatening disease.
• Patients with a history of allergic reactions to tetracyclines or any excipients contained in the formulation of the study medication.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 2 центра

• Peking University Third Hospital — Пекин
• Peking University Third Hospital — Пекин

Идентификаторы

NCT: NCT06670872 · M2024219

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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