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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ventilator Associated Pneumonia, Antibiotic Resistant Infection

Intervention / Treatment
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* Drug: Ceftolozane/tazobactam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| C/T<br>C/T cases: individuals fulfilling eligibility criteria and treated with ceftolozane-tazobactam | Drug: Ceftolozane/tazobactam<br>* Administration<br>|
| C<br>C cases: individuals fulfilling eligibility criteria and treated with colomycine | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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) |