A Study on the Combination Therapy of Eravacycline for Treating Carbapenem-Resistant Acinetobacter Baumannii Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- clinical efficacy at the end of treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Eravacycline combination therapy group
Eravacycline is administered intravenously at a dosage of 1mg/kg, once every 12 hours. The duration of intravenous infusion is approximately 60 minutes.The combined drugs include sulbactam or compound preparations containing sulbactam, polymyxin B, beta-lactam antibiotics, etc., used according to their instructions for use or clinical practice guidelines.
干预措施: Eravacycline combination therapy group (Drug)
结局指标
主要结局
clinical efficacy at the end of treatment
时间窗: up to the end of treatment, up to 4 weeks(estimation)
The primary endpoint is the clinical efficacy at the end of treatment (within 24 hours after the last dose of the trial medication) for all patients who have completed the trial according to the protocol. Clinical efficacy is assessed and the clinical response rate is calculated. Clinical response is evaluated by PI，and defined as an improvement, reduction, or disappearance of the patient's multiple symptoms and signs compared to before treatment, along with improvement or normalization of imaging findings. Clinical response rate = (number of patients with symptom relief) / (total number of patients included in the study).
次要结局
- Incidence Rate of Adverse Event(up to the end of treatment, up to 4 weeks(estimation))
- The microbiological clearance rate(up to the end of treatment, up to 4 weeks(estimation))
- The all cause mortality rate(28 days)
研究者
WangFei
chief physician
Peking University Third Hospital