Status:
RECRUITING
Ceftolozane/Tazobactam Versus Meropenem for Febrile Neutropenia on Patients Colonized With or at Risk for Infection With Extended Spectrum Beta Lactamase - Producing Pathogens
Lead Sponsor:
Beneficência Portuguesa de São Paulo
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Febrile Neutropenia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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: \- A...
Eligibility Criteria
Inclusion criteria:
- Individuals who present with the onset of febrile neutropenia and at the same time present colonization with an ESBL-producing pathogen (identified through positive routine rectal swabs and/or positive culture of clinical specimen) or risk of infection with an ESBL-producing pathogen (use of 3rd/4th gen cephalosporin or piperacillin/tazobactam for at least 48 hours in the last 30 days).
Exclusion Criteria:
- Patients known to be colonized with carbapenem-resistant or CEF/TAZ-resistant pathogens
- Patients with previous use of carbapenems for at least 48h in the past 30 days are also excluded due to risk of resistance to the study drugs.
- Growth of a pathogen resistant to either study drug in a relevant clinical specimen during the intervention phase will be followed by adjustment of therapy according to local protocol, unblinding, and exclusion from the study.
- Patients that have received less than 72h of either study drug will also be excluded from the final analyses.
Key Trial Info
Start Date :
March 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT06342115
Start Date
March 26 2025
End Date
December 1 2026
Last Update
May 2 2025
Active Locations (1)
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1
A Beneficência Portuguesa de São Paulo
São Paulo, Brazil