Recruiting PHASE4 Febrile Neutropenia

Compares treatment options for Febrile Neutropenia

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

ClinicalTrials.gov ID: NCT06342115

What this study is testing

What is Ceftolozane-Tazobactam?

Ceftolozane-Tazobactam is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for febrile neutropenia.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 4: studies an already-approved treatment
  • This is a blinded study.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • \- Individuals who present with the onset of febrile neutropenia and at the same time present colonization with an ESBL-producing pathogen...

You likely can't join if

  • 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...
  • Patients that have received less than 72h of either study drug will also be excluded from the final analyses.

The study team makes the final eligibility decision.

Where it's taking place

  • São Paulo, Brazil

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.