Ceftolozane/Tazobactam Versus Meropenem for Febrile Neutropenia on Patients Colonized With or at Risk for Infection With Extended Spectrum Beta Lactamase (ESBL)-Producing Pathogens: a Randomized Double-blind Non-inferiority Trial.

What this Trial Is About

Researchers are evaluating the effectiveness and tolerability of Ceftolozane/tazobactam compared to the standard treatment, Meropenem, in patients with febrile neutropenia who are colonized with or at risk for infections caused by extended-spectrum beta-lactamase (ESBL)-producing pathogens. This is a planned, double-blind, randomized, non-inferiority clinical trial aiming to assess clinical response, toxicity, and microbiological changes in this patient population. Participants will be randomly assigned to receive either 3g of Ceftolozane/tazobactam or 2g of Meropenem intravenously every 8 hours. The treatment duration will follow local guidelines, allowing adjustment after identifying the causative pathogens. The study includes stool sample collections before, during, and after treatment to analyze intestinal microbiota and microbiome effects, particularly regarding graft versus host disease (GVHD). During the trial, researchers will monitor clinical cure rates at the end of therapy and test-of-cure visits, microbiologically documented infections, mortality, incidence of GVHD, and multidrug-resistant infections for up to 100 days post-treatment. Safety is tracked through adverse events and serious adverse events up to 35 days after the last dose. The trial's total participation timeline includes therapy duration and follow-up assessments, ensuring thorough evaluation of treatment impact and safety.

Ceftolozane/Tazobactam Versus Meropenem for Febrile Neutropenia on Patients Colonized With or at Risk for Infection With Extended Spectrum Beta Lactamase - Producing Pathogens