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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.

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04352855
Enrollment
55
Registered
2020-04-20
Start date
2018-01-18
Completion date
2020-05-19
Last updated
2020-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Associated Pneumonia, Antibiotic Resistant Infection

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.

Interventions

Administration

Sponsors

Semmelweis University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 90 Years

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

Design outcomes

Primary

MeasureTime frame
Clinical cure rate7-14 day
Microbiological cure rate7-14 day

Secondary

MeasureTime frameDescription
LOS28Lenght of ICU stay
Length of ventilationUntill patient is ventilated (expected time frame is 10 days)
28 day mortality28
Drug related adverse events rateuntil ICU discharge (expected average day is 14)The number and nature

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026