Comparing Ceftolozane/Tazobactam and Meropenem for Febrile Neutropenia in Patients at Risk for ESBL Infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• A Beneficência Portuguesa de São Paulo
  São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: João Prats, MD — Beneficência Portuguesa de São Paulo
• Study coordinator: Research Department
• Email: naipe@bp.org.br
• Phone: +55 11 3505 5031

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Plasma Host-Microbe Proteomics to Predict Complications in High-Risk Febrile Neutropenia

  Researchers will test a combined host and microbial blood proteome to see if it can predict which high-risk febrile neutropenia patients will develop complications.

  Recruiting Instituto de Investigación Biomédica de Salamanca · Barcelona, Barcelona and 2 other locations · NCT07277387

• Stepwise antibiotic and antifungal treatment for febrile neutropenia in blood cancer patients

  This treatment plan tests whether a stepwise escalation of antibiotics and antifungals can control infection and fever in adults with hematologic malignancies who develop febrile neutropenia.

  Recruiting Shanxi Bethune Hospital · Taiyuan, Shanxi · NCT07204522

• Adjusting antibiotic doses for children with cancer and infections

  This study is testing how to adjust antibiotic doses for children with cancer who have infections to make sure they get the right amount of medicine when their kidneys clear it from their bodies too quickly.

  Recruiting Phase 4 Centre Hospitalier Universitaire Vaudois · Lausanne, Canton of Vaud · NCT06293677

• Using next-generation sequencing to detect infections in neutropenic patients with fever

  This study is testing a new method using advanced DNA technology to see if it can help doctors quickly find infections in patients with low white blood cell counts and fever.

  Recruiting at 6 sites University Hospital of Cologne · Cologne and 5 other locations · NCT05815628

• G-CSF–fusion protein to prevent chemotherapy neutropenia in children with sarcoma

  This trial tests Albipagrastim alfa (QLC2519) in children with sarcoma to see if it helps prevent chemotherapy-induced neutropenia.

  Recruiting Phase 2 Qilu Pharmaceutical Co., Ltd. · Beijing · NCT07724756

• Personalized antibiotic duration for high-risk febrile neutropenia with Gram-negative bloodstream infection

  This trial tests whether stopping antibiotics after a patient with a blood cancer and febrile neutropenia has been clinically stable for 72 hours is as safe and lets them spend more days off anti–Gram-negative antibiotics than the usual at least 10-day approach.

  Recruiting Humanitas University · Rozzano, Milan · NCT07372131

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.