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

Ventilator Associated Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04352855
• Other study ID #: SE58/2020
• Status: Active, not recruiting
• Start date: January 18, 2018
• Est. completion date: May 19, 2020

Study information

• Verified date: April 2020
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: May 19, 2020
• Est. primary completion date: May 19, 2020
• Gender: All
• Age group: 16 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Resistant Infection
• Communicable Diseases
• Infection
• Pneumonia
• Pneumonia, Ventilator-Associated
• Respiratory Tract Infections
• Ventilator Associated Pneumonia

Intervention

Drug:
• Ceftolozane/tazobactam
Administration

Locations

Country	Name	City	State
Hungary	Semmelweis University	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical cure rate		7-14 day
Primary	Microbiological cure rate		7-14 day
Secondary	LOS	Lenght of ICU stay	28
Secondary	Length of ventilation		Untill patient is ventilated (expected time frame is 10 days)
Secondary	28 day mortality		28
Secondary	Drug related adverse events rate	The number and nature	until ICU discharge (expected average day is 14)