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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A Beneficência Portuguesa de São Paulo

São Paulo, Brazil