Clinical trial NCT04352855: Ceftolozane-tazobactam for the Treatment of Respiratory Infections Due to Extensively Drug-resistant Pseudomonas Aeruginosa Among Critically Ill Patients: a Retrospective Study.
Official title: Ceftolozane-tazobactam for the Treatment of Respiratory Infections Due to Extensively Drug-resistant Pseudomonas Aeruginosa Among Critically Ill Patients: a Retrospective Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventilator Associated Pneumonia
Antibiotic Resistant Infection
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 55
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical cure rate
timeFrame: 7-14 day
measure: Microbiological cure rate
timeFrame: 7-14 day
Secondary outcomes:
measure: LOS
timeFrame: 28
measure: Length of ventilation
timeFrame: Untill patient is ventilated (expected time frame is 10 days)
measure: 28 day mortality
timeFrame: 28
measure: Drug related adverse events rate
timeFrame: until ICU discharge (expected average day is 14)
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University
Study officials:
References: