跳至主要内容
临床试验/NCT04352855
NCT04352855Unknown不适用

Ceftolozane-tazobactam for the Treatment of Respiratory Infections Due to Extensively Drug-resistant Pseudomonas Aeruginosa Among Critically Ill Patients: a Retrospective Study.

Semmelweis University1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2018年1月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
55
试验地点
1
主要终点
Clinical cure rate

研究概览

简要总结

The aim of this study is to report our experience with ceftolozane-tazobactam and to evaluate its safety and efficacy in the treatment of ICU dependent nosocomial respiratory tract infections due to extensively drug resistant Pseudomonas aeruginosa. Different dosing regimes of ceftalozane-tazobactam is evaluated and compared to the standard therapy of Colomycin.

详细描述

Ceftolozane-tazobactam (C/T) is a novel type of beta-lactam/beta-lactamase inhibitor antibiotics targeting nosocomial infections caused by Gram-negative bacteria. In recent years, ceftolozane-tazobactam was prescribed for treating complicated urinary tract infections (cUTI) and complicated intraabdominal infections (cIAI). Following the results of ASPECT-NP trial in 2019, it was approved as a therapeutic option in nosocomial pneumonia including hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP).

The drug shows an excellent activity against ESBL-producing Enterobacterales and multidrug-resistant (MDR) and extensively drug-resistant (XDR) strains of Pseudomonas aeruginosa. The latter is widely recognized as a common pathogen of nosocomial respiratory tract infections.

There is still a need for observations of clinical experiences to better define the risk-benefit profile of ceftolozane-tazobactam. The aim of this study is to report our experience with ceftolozane-tazobactam and to evaluate its safety and efficacy in the treatment of ICU dependent nosocomial respiratory tract infections due to extensively drug resistant Pseudomonas aeruginosa. Different dosing regimes of ceftalozane-tazobactam is evaluated and compared to the standard therapy of Colomycin.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospital-acquired pneumonia caused by extensively drug-resistant Pseudomonas aeruginosa
  • ≥ 72 hours of targeted antibiotic therapy against Pseudomonas aeruginosa with either Colomycin or Ceftolozane-Tazobactam

排除标准

  • Participation in an interventional trial aiming nosocomial infections
  • Treatment was not with the intent to cure the infection

研究组 & 干预措施

C/T

C/T cases: individuals fulfilling eligibility criteria and treated with ceftolozane-tazobactam

干预措施: Ceftolozane/tazobactam (Drug)

结局指标

主要结局

Clinical cure rate

时间窗: 7-14 day

Microbiological cure rate

时间窗: 7-14 day

次要结局

  • LOS(28)
  • 28 day mortality(28)
  • Length of ventilation(Untill patient is ventilated (expected time frame is 10 days))
  • Drug related adverse events rate(until ICU discharge (expected average day is 14))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zsolt Iványi

Associate professor

Semmelweis University

研究点 (1)

Loading locations...

相似试验

Ceftolozane-tazobactam for the Treatment of... | 临床试验