Evaluation of Usage Patterns and Outcomes in Patients Receiving Ceftolozane/Tazobactan (C/T) in Brazilian Hospitals
NCT ID: NCT05267483
Last Updated: 2022-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2022-04-01
2023-03-30
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
2. received at least 2 days of C/T (with or without other antibiotics).
Exclusion Criteria
18 Years
ALL
No
Sponsors
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D'Or Institute for Research and Education
OTHER
Responsible Party
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Principal Investigators
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Fernando Bozza, PhD
Role: PRINCIPAL_INVESTIGATOR
D'Or Institute for Research and Education (IDOR)
Locations
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D'Or Institute for Research and Education (IDOR)
Rio de Janeiro, , Brazil
Countries
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Other Identifiers
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15054519.3.0000.5249
Identifier Type: -
Identifier Source: org_study_id
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