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

• Conditions: Antibiotic Resistant Infection; Ventilator Associated Pneumonia
• Interventions: Drug: Ceftolozane/tazobactam

• Registration Number: NCT04352855
• Lead Sponsor: Semmelweis University

Brief Summary

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.

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.

Study Timeline

• Study Start: 2018-01-18
• Status Verified: 2020-04
• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-15
• Last Update Submitted: 2020-04-15
• Study First Posted: 2020-04-20
• Last Update Posted: 2020-04-20
• Primary Completion: 2020-05-19
• Study Completion: 2020-05-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
C/T	Ceftolozane/tazobactam	C/T cases: individuals fulfilling eligibility criteria and treated with ceftolozane-tazobactam

Primary Outcome Measures

Name	Time	Method
Clinical cure rate	7-14 day
Microbiological cure rate	7-14 day

Secondary Outcome Measures

Name	Time	Method
LOS	28	Lenght of ICU stay
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)	The number and nature

Trial Locations

Locations (1)

Semmelweis University; 🇭🇺 Budapest, Hungary