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

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 Overview

• Status: Unknown
• Conditions: Ventilator Associated Pneumonia; Antibiotic Resistant Infection
• Intervention / Treatment: Drug: Ceftolozane/tazobactam

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 Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1085
    • Semmelweis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to a multideisciplanry academic terciary care ICU, suffering from ventilation associated pneumonia, caused by XDR or panresistant Pseudomonas Aeruginosa

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
C/T; C/T cases: individuals fulfilling eligibility criteria and treated with ceftolozane-tazobactam	Drug: Ceftolozane/tazobactam; Administration
C; C cases: individuals fulfilling eligibility criteria and treated with colomycine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical cure rate	7-14 day
Microbiological cure rate	7-14 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Semmelweis University

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2018
• Primary Completion (Anticipated): May 19, 2020
• Study Completion (Anticipated): May 19, 2020

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 20, 2020
• Last Update Submitted That Met QC Criteria: April 15, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Infections; Communicable Diseases; Respiratory Tract Infections; Pneumonia, Ventilator-Associated; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Tazobactam; Ceftolozane; Ceftolozane, tazobactam drug combination
• Other Study ID Numbers: SE58/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No