Clinical Outcomes With Ceftolozane-tazobactam for MDR Pseudomonas Infections

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

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.

Study Overview

• Status: Unknown
• Conditions: Pseudomonas Infections; Pseudomonas Aeruginosa
• Intervention / Treatment: Drug: Ceftolozane-Tazobactam

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University, School of Pharmacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who had Pseudomonas aeruginosa infection and received ceftolozane-tazobactam for at least 24 hrs for treatment.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treated subjects; All patients with Pseudomonas infections treated with ceftolozane-taezobactam who meet the inclusion criteria	Drug: Ceftolozane-Tazobactam; Subjects treated with ceftolozane-tazobactam for Pseudomonas infections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	30-day mortality	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiological cure	Negative repeated bacterial cultures collected from site of infection	Up to 12 weeks

Collaborators and Investigators

• Sponsor: Temple University
• Investigators: Study Chair: Peter Doukas, Ph.D, Temple University - School of Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Anticipated): February 28, 2019
• Study Completion (Anticipated): February 28, 2019

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 27, 2018

Study Record Updates

• Last Update Posted (Actual): April 27, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Pseudomonas Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Tazobactam; Ceftolozane; Ceftolozane, tazobactam drug combination
• Other Study ID Numbers: Gallagher

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No