Actively Recruiting
Ceftolozane/Tazobactam Versus Meropenem for Febrile Neutropenia on Patients Colonized With or at Risk for Infection With Extended Spectrum Beta Lactamase - Producing Pathogens
Led by Beneficência Portuguesa de São Paulo · Updated on 2025-05-02
176
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
Sponsors
B
Beneficência Portuguesa de São Paulo
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
The study proposes a planned, double-blind, non-inferiority clinical trial involving patients with febrile neutropenia and risk of extended-spectrum beta-lactamase (ESBL) infection. The goal is: \- Analyze the efficacy and tolerability of Ceftolozane/tazobactam (CEF/TAZ) compared to the current standard of care (meropenem) in patients with febrile neutropenia and risk of ESBL infection. Patients will be randomly assigned to receive CEF/TAZ or meropenem, with assessment of clinical response, toxicity and microbiological evolution. Stool samples will be collected before, during and after treatment for intestinal microbiota analysis and intestinal microbiome analysis to evaluate possible effects on GVHD. Analysis of the results will include the taxonomic classification of the organisms present. Data will be analyzed to assess non-inferiority in clinical response, incidence of GVHD, antimicrobial resistance and other outcomes.
CONDITIONS
Official Title
Ceftolozane/Tazobactam Versus Meropenem for Febrile Neutropenia on Patients Colonized With or at Risk for Infection With Extended Spectrum Beta Lactamase - Producing Pathogens
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals with onset of febrile neutropenia
- Colonization with an ESBL-producing pathogen confirmed by rectal swabs or clinical cultures
- Or at risk of ESBL infection due to using 3rd/4th generation cephalosporin or piperacillin/tazobactam for at least 48 hours in the last 30 days
You will not qualify if you...
- Known colonization with carbapenem-resistant or Ceftolozane-Tazobactam-resistant pathogens
- Previous use of carbapenems for at least 48 hours in the past 30 days
- Growth of a pathogen resistant to either study drug during treatment phase
- Received less than 72 hours of either study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
A Beneficência Portuguesa de São Paulo
São Paulo, Brazil
Actively Recruiting
Research Team
R
Research Department
CONTACT
B
Bianca Verboski
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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