Comparing Ceftolozane/Tazobactam and Meropenem for Febrile Neutropenia in Patients at Risk for ESBL Infections
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.
This study is testing if a new antibiotic called Ceftolozane/Tazobactam works just as well as Meropenem for people with febrile neutropenia who are at risk for certain infections.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beneficência Portuguesa de São Paulo Academic / other |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT06342115 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a double-blind, non-inferiority study that evaluates the efficacy and tolerability of Ceftolozane/Tazobactam compared to Meropenem in patients experiencing febrile neutropenia who are at risk for infections caused by extended-spectrum beta-lactamase (ESBL) producing pathogens. Participants will be randomly assigned to receive either treatment, and their clinical responses, toxicity levels, and microbiological changes will be assessed. Stool samples will be collected to analyze the intestinal microbiota and its potential effects on graft-versus-host disease (GVHD). The study aims to determine if Ceftolozane/Tazobactam is as effective as Meropenem while also monitoring for antimicrobial resistance and other outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals presenting with febrile neutropenia and colonization or risk of infection with ESBL-producing pathogens.
Not a fit: Patients known to be colonized with carbapenem-resistant or Ceftolozane/Tazobactam-resistant pathogens may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with febrile neutropenia at risk for ESBL infections, potentially improving clinical outcomes.
How similar studies have performed: Other studies have shown promise in evaluating similar antibiotic treatments, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
São Paulo
- A Beneficência Portuguesa de São Paulo — São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: João Prats, MD — A Beneficência Portuguesa de São Paulo
- Study coordinator: Research Department
- Email: naipe@bp.org.br
- Phone: +55 11 3505 5031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.