跳至主要内容
临床试验/NCT06992102
NCT06992102已完成不适用

Clinical Study on the Treatment of Lower Respiratory Tract Infection With Pseudomonas Aeruginosa by Ceftazidime and Avibatam

The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
1
主要终点
Clinical efficacy

研究概览

简要总结

Multidrug-resistant Gram-negative bacteria (MDR-GNB) is emerging globally as a pathogen of concern in healthcare-associated infections (HAIs), and a threat to public health.There has been an alarming rise in the prevalence of MDR-GNB infections globally over the last decade.Multidrug-resistant or Carbapenem-resistant Pseudomonas aeruginosa (MDRPA or CRPA) are one of the major pathogens in the hospital setting,and are particularly challenging due to limited therapeutic options,associated with high mortality rates.Ceftazidime/avibactam(CAZ/AVI) combines the anti-pseudomonal cephalosporin ceftazidime and the novel non-β-lactam β-lactamase inhibitor avibactam,which are now available for the treatment of MDR-GNB infections and favorable outcomes have been reported in hospitalized patients with carbapenem-resistant Enterobacterales (CRE).However, there are only few publications available with a small sample size limit, focusing on the efficacy of CAZ/AVI for the treatment of CRPA or MDRPA infections.Therefore, a retrospective analysis was conducted to compare the clinical efficacy and microbiological efficacy of CAZ/AVI versus other antibiotics for the treatment of MDRPA infections.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with MDRPA infection diagnosed by clinicians
  • patients treated with anti-Pseudomonas aeruginosa antibiotics for at least 72h
  • patients older than 18 years old.

排除标准

  • Patients with human immunodeficiency virus infection, mental illness, a medication course of less than 72 hours, or incomplete data were excluded.

结局指标

主要结局

Clinical efficacy

时间窗: 28 day after enrollment

The clinical efficacy of the treatment was determined by two senior physicians with extensive clinical experience, who classified it as either effective (characterized by the resolution or significant improvement of clinical symptoms and signs, normalization or minimal residuals in pulmonary imaging, and normalization of inflammatory markers), uncertain or ineffective.

次要结局

  • Microbiological efficacy(28 day after enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验