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

NCT04352855 | Unknown

• 1 other identifier: SE58/2020
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Associated Pneumonia; Antibiotic Resistant Infection

Outcome Measures

Primary Outcomes (2)

• Clinical cure rate

  7-14 day

• Microbiological cure rate

  7-14 day

Secondary Outcomes (4)

• LOS

  28

• Length of ventilation

  Untill patient is ventilated (expected time frame is 10 days)

• 28 day mortality

  28

• Drug related adverse events rate

  until ICU discharge (expected average day is 14)

Study Arms (2)

C/T

C/T cases: individuals fulfilling eligibility criteria and treated with ceftolozane-tazobactam

Drug: Ceftolozane/tazobactam

C

C cases: individuals fulfilling eligibility criteria and treated with colomycine

Interventions

Ceftolozane/tazobactam DRUG

Administration

C/T

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Participation in an interventional trial aiming nosocomial infections
• Treatment was not with the intent to cure the infection

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University

Budapest, 1085, Hungary

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

ceftolozane, tazobactam drug combination

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 20, 2020
• Study Start: January 18, 2018
• Primary Completion: May 19, 2020
• Study Completion: May 19, 2020
• Last Updated: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)