Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05267483 |
| Other study ID # |
15054519.3.0000.5249 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2022 |
| Est. completion date |
March 30, 2023 |
Study information
| Verified date |
March 2022 |
| Source |
D'Or Institute for Research and Education |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
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).
