Clinical Outcomes With Ceftolozane-tazobactam for MDR Pseudomonas Infections

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.

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