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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: May 19, 2020

Detailed Description

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.

Interventions

  • Drug: Ceftolozane/tazobactam
    • Administration

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Clinical cure rate
    • Time Frame: 7-14 day
  • Microbiological cure rate
    • Time Frame: 7-14 day

Secondary Measures

  • LOS
    • Time Frame: 28
    • Lenght of ICU stay
  • Length of ventilation
    • Time Frame: Untill patient is ventilated (expected time frame is 10 days)
  • 28 day mortality
    • Time Frame: 28
  • Drug related adverse events rate
    • Time Frame: until ICU discharge (expected average day is 14)
    • The number and nature

Participating in This Clinical Trial

Inclusion Criteria

  • 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

Exclusion Criteria

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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 90 Years

Investigator Details

  • Lead Sponsor
    • Semmelweis University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zsolt Iványi, Associate professor – Semmelweis University

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