Clinical Outcomes With Ceftolozane-tazobactam for MDR Pseudomonas Infections

Pseudomonas Aeruginosa Clinical Trial

Official title:

Clinical Outcomes With Ceftolozane-tazobactam in Patients With Multi Drug Resistant (MDR) Pseudomonas Aeruginosa Infections

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03510351
• Other study ID #: Gallagher
• Status: Active, not recruiting
• First received: November 27, 2017
• Last updated: April 17, 2018
• Start date: February 1, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: April 2018
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will describe clinical outcomes in patients who received ceftolozane-tazobactam for a Pseudomonas aeruginosa infection. Primary outcomes include 30-day and in-hospital mortality.

Description:

Very little data is available to evaluate the use of ceftolozane-tazobactam in MDR Pseudomonas aeruginosa infections. Additionally, there is currently no standard recommendation for the treatment of MDR Pseudomonas aeruginosa infections, and multiple agents are often used in combination which increases the probability of adverse effects in addition to leading to possibly more resistance and higher costs of care. This is particularly relevant since the primary alternative drugs for MDR Pseusomonas aeruginosa infections are aminoglycosides and polymyxins, two categories of agents with significant adverse effects and suboptimal pharmacokinetics that limit efficacy.

This is a multicenter study designed to collect retrospective data on clinical outcomes of patients treated with ceftolozane-tazobactam in the hospital. The primary outcomes include 30-day and in-hospital mortality. Microbiological and clinical cure will be assessed as secondary outcomes. Microbiological outcomes will be defined as: cure- a repeat culture was negative; failure- repeat cultures were not negative or the patient died before repeat cultures could be obtained; presumed cure- repeat cultures were not taken but clinical cure occurred. Clinical outcomes will be defined as: clinical success- signs and symptoms o the index infection resolved at the end of therapy; clinical failure- signed and symptoms remained at the end of therapy or the patient died; indeterminate- it was not possible to determine the clinical outcome at the end of therapy.

Patient information will be collected from Temple University Hospital as well as 20 other hospital sites. The source population will be all adult patients who received ceftolozane-tazobactam for greater than 24 hours in each of the hospital sites between December 19, 2014 and December 31, 2016. Participating hospital sites will review clinical charts to identify and enroll a target of 5-15 subjects per site. We have a targeted enrollment of 200 subjects. All involved parties will use the Research Electronic Data Capture (RedCap) database based at Temple University for data collection and storage.

We will be utilizing existing electronic data and will have no direct contact with or recruit research subjects. Because this is a study with retrospective data collection, enrolled patients will have received treatment as determined by the treating physicians in accordance with standard of care. To limit bias in the selection of subjects, investigators will be asked to identify and consecutively enroll all eligible patients treated with ceftolozane-tazobactam within the study period.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Greater than 18 years old

• Cultures positive Pseudomonas aeruginosa from any source

• Received ceftolozane-tazobactam for at least 24 hrs

Exclusion Criteria:

• Protected populations

• Prisoners, pregnant women, children

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Pseudomonas Aeruginosa
• Pseudomonas Infections

Intervention

Drug:
• Ceftolozane-Tazobactam
Subjects treated with ceftolozane-tazobactam for Pseudomonas infections

Locations

Country	Name	City	State
United States	Temple University, School of Pharmacy	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	30-day mortality	30 days
Secondary	Microbiological cure	Negative repeated bacterial cultures collected from site of infection	Up to 12 weeks