SepsisNCT05267483
Evaluation of Usage Patterns and Outcomes in Patients Receiving Ceftolozane/Tazobactan (C/T) in Brazilian Hospitals
An observational study of Sepsis, run by D'Or Institute for Research and Education at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2022to 30 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- aged > 18 years
- received at least 2 days of C/T (with or without other antibiotics).
Who cannot join
- 1) Patients who were not hospitalized in the ICU.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
D'Or Institute for Research and Education (IDOR)
Rio de Janeiro, 22281-100
About this study
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.
Read the 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).
- Conditions
- Sepsis
- Being tested
- No intervention
- Keywords
- Multidrug-Resistant (MDR) Bacterial Infections, Intensive Care Unit, Antibiotics, Ceftolozane/Tazobactan
- Medical subject headings
- Sepsis, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful clinical infection resolution
Complete resolution of clinical signs and symptoms related to the infection treated by C/T and lack of microbiological evidence of infection
Measured: 30 days
Clinical failure
Defined as either lack of clinical response and/or recurrence and/or attributable mortality due to the infection.
Measured: 30 Days
Secondary outcomes (1)
ICU mortality and hospital 30-d mortality
30 Days hospital mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start1 Apr 2022 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D'Or Institute for Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernando Bozza, PhD, Principal investigator, D'Or Institute for Research and Education (IDOR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267483
- Sponsor's protocol ID
- 15054519.3.0000.5249
- Status last verified
- Mar 2022
- First submitted
- 24 Feb 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Usage Patterns and Outcomes in Patients Receiving Ceftolozane/Tazobactan (C/T) in Brazilian Hospitals
- ClinicalTrials.gov ID
- NCT05267483
- Acronym / sponsor ID
- 15054519.3.0000.5249
- Conditions
- Sepsis
- Keywords
- Multidrug-Resistant (MDR) Bacterial Infections, Intensive Care Unit, Antibiotics, Ceftolozane/Tazobactan
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- D'Or Institute for Research and EducationUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 4 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- aged > 18 years
- received at least 2 days of C/T (with or without other antibiotics).
Key exclusion criteria (1 listed)
- 1) Patients who were not hospitalized in the ICU.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
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
Clinical failure
Time frame: 30 Days
Defined as either lack of clinical response and/or recurrence and/or attributable mortality due to the infection.
1 secondary outcome
ICU mortality and hospital 30-d mortality
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Bozza, PhD principal investigator
D'Or Institute for Research and Education (IDOR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by D'Or Institute for Research and Education at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful clinical infection resolution (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.