Evaluation of Usage Patterns and Outcomes in Patients Receiving Ceftolozane/Tazobactan (C/T) in Brazilian Hospitals

March 28, 2022 updated by: D'Or Institute for Research and Education

Ceftolozane/Tazobactan (C/T) is a recent option to manage multidrug resistant gram-negative infections in hospital patients. Despite several randomized controlled trials describing safety and efficacy of C/T, real world evidence of its use, including indications, length of treatment and outcomes are lacking.

Understanding prescribing patterns of a new drug may help identifying possible knowledge gaps to target future randomized controlled trials. Additionally, real world evidence may help identifying practices and outcomes outside a clinical trial context.

Study Overview

Status

Enrolling by invitation

Conditions

Sepsis

Intervention / Treatment

Other: No intervention

Detailed Description

A multicenter, retrospective real-world study of hospitalized patients in a large private network of hospitals in Brazil (Rede D´Or São Luiz). Clinical data will be collected from Epimed Monitor Database®, an intensive care unit quality improvement database, which is in use over 1500 ICU beds, providing structured information on demographic, administrative and physiological parameters, as well as detailed data regarding the use of intensive care unit resources, infectious episodes, adverse events and checklists for adherence to best clinical practices. The pharmacy data is integrated from all hospitals in a single database, including clinical dosage, dosage form, route, dose regimen, duration of therapy. All sites are linked to a central microbiology lab with automatized systems and central online data. Data from Epimed®, pharmacist and business intelligence databases will be merged and medical records will be reviewed for the following information, which will be entered in a dedicated RedCap® form.

Indication for C/T as well as dosage, type of infusion and duration will be reviewed by a pharmacist and an infectious disease specialist. Reason for ceftolozane/tazobactam use was identified via medical record: physician notes, prescription changes and culture results.

Adverse events will be evaluated by an experienced pharmacist using a validated methodology (Naranjo algorithm).

Patient and infection outcome are classified as successful or failure at the end of the follow-up period. Patient outcome include ICU mortality and hospital 30-d mortality. A successful clinical infection resolution is defined as complete resolution of clinical signs and symptoms related to the infection treated by C/T and lack of microbiological evidence of infection. Clinical failure was defined as either lack of clinical response and/or recurrence and/or attributable mortality due to the infection. Outcomes will be stratified by C/T indication reason: initial empiric therapy, target therapy and failure of prior antibiotic therapy.

Cultures, identification of the organisms and susceptibility testing are performed at each participating center according to their own practice or by the central microbiology lab. The isolates are identified in genus and species by the VITEK® MS MALDI-TOF (bioMérieux - France) mass spectrometry methodology, and sensitivity and resistance criteria is defined using recent CLSI MIC breakpoints - M100, 28th Ed (Clinical and Laboratory Standards Institute - 2019).

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Brazil
- - Rio De Janeiro, Brazil, 22281-100
    - D'Or Institute for Research and Education (IDOR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized patients in a large private network of hospitals in Brazil with severe infections, receiving ceftolozane/tazobactam for the treatment of proven or suspected infections.

Description

Inclusion Criteria:

aged > 18 years
received at least 2 days of C/T (with or without other antibiotics).

Exclusion Criteria:

1) Patients who were not hospitalized in the ICU.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful clinical infection resolution Time Frame: 30 days	Complete resolution of clinical signs and symptoms related to the infection treated by C/T and lack of microbiological evidence of infection	30 days
Clinical failure Time Frame: 30 Days	Defined as either lack of clinical response and/or recurrence and/or attributable mortality due to the infection.	30 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU mortality and hospital 30-d mortality Time Frame: 30 days	30 Days hospital mortality	30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

D'Or Institute for Research and Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

November 30, 2022

Study Completion (Anticipated)

March 30, 2023

Study Registration Dates

First Submitted

February 24, 2022

First Submitted That Met QC Criteria