NCT06342115 Ceftolozane/Tazobactam Versus Meropenem for Febrile Neutropenia on Patients Colonized With or at Risk for Infection With Extended Spectrum Beta Lactamase - Producing Pathogens
| NCT ID | NCT06342115 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Beneficência Portuguesa de São Paulo |
| Condition | Febrile Neutropenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 176 participants |
| Start Date | 2025-03-26 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 176 participants in total. It began in 2025-03-26 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. Patients will be randomly assigned to receive CEF/TAZ or meropenem, with assessment of clinical response, toxicity and microbiological evolution. Stool samples will be collected before, during and after treatment for intestinal microbiota analysis and intestinal microbiome analysis to evaluate possible effects on GVHD. Analysis of the results will include the taxonomic classification of the organisms present. Data will be analyzed to assess non-inferiority in clinical response, incidence of GVHD, antimicrobial resistance and other outcomes.
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.
Contact & Investigator
João Prats, MD
PRINCIPAL INVESTIGATOR
A Beneficência Portuguesa de São Paulo
Frequently Asked Questions
Who can join the NCT06342115 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Febrile Neutropenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06342115 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06342115 currently recruiting?
Yes, NCT06342115 is actively recruiting participants. Contact the research team at naipe@bp.org.br for enrollment information.
Where is the NCT06342115 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT06342115 clinical trial?
NCT06342115 is sponsored by Beneficência Portuguesa de São Paulo. The principal investigator is João Prats, MD at A Beneficência Portuguesa de São Paulo. The trial plans to enroll 176 participants.