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

Launched by BENEFICÊNCIA PORTUGUESA DE SÃO PAULO · Mar 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different antibiotics, Ceftolozane/Tazobactam (CEF/TAZ) and Meropenem, to see which one works better for patients who have febrile neutropenia—a condition where a person has a fever and low white blood cell counts, making them more susceptible to infections. The trial specifically focuses on patients who are at risk for infections caused by certain bacteria called extended-spectrum beta-lactamase (ESBL) producers. Researchers want to find out if CEF/TAZ is just as effective and safe as Meropenem in treating these patients.

To participate in this study, individuals need to have febrile neutropenia and either be colonized with or at risk for infection from ESBL-producing bacteria. They will be randomly assigned to receive either CEF/TAZ or Meropenem, and their health will be closely monitored throughout the treatment. This includes collecting stool samples to analyze the effects on gut bacteria and any potential complications. It’s important to note that certain patients, such as those previously treated with specific types of antibiotics or those with resistant infections, will not be eligible for this trial. Overall, the study aims to provide valuable information on the best treatment options for patients at risk of these infections.

Gender

ALL

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.