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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)

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