NCT05267483

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

8 months

First QC Date

February 24, 2022

Last Update Submit

March 28, 2022

Conditions

Sepsis

Keywords

Multidrug-Resistant (MDR) Bacterial InfectionsIntensive Care UnitAntibioticsCeftolozane/Tazobactan

Outcome Measures

Primary Outcomes (2)

  • 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

    30 days

  • Clinical failure

    Defined as either lack of clinical response and/or recurrence and/or attributable mortality due to the infection.

    30 Days

Secondary Outcomes (1)

  • ICU mortality and hospital 30-d mortality

    30 days

Interventions

No interventionOTHER

No intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • \) Patients who were not hospitalized in the ICU.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

D'Or Institute for Research and Education (IDOR)

Rio de Janeiro, 22281-100, Brazil

Location

MeSH Terms

Conditions

SepsisBacterial Infections

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsBacterial Infections and Mycoses

Study Officials

  • Fernando Bozza, PhD

    D'Or Institute for Research and Education (IDOR)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2022

First Posted

March 4, 2022

Study Start

April 1, 2022

Primary Completion

November 30, 2022

Study Completion

March 30, 2023

Last Updated

April 6, 2022

Record last verified: 2022-03

Locations

BR(1)