protocolSection identificationModule nctId: NCT06342115, orgStudyIdInfo id: CLEMENT TRIAL, briefTitle: Ceftolozane/Tazobactam Versus Meropenem for Febrile Neutropenia on Patients Colonized With or at Risk for Infection With Extended Spectrum Beta Lactamase - Producing Pathogens, acronym: CLEMENT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Beneficência Portuguesa de São Paulo, class: OTHER, collaborators name: Merck Sharp & Dohme LLC, descriptionModule briefSummary: 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., conditionsModule conditions: Febrile Neutropenia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 176, type: ESTIMATED, armsInterventionsModule interventions name: Ceftolozane-Tazobactam, interventions name: Meropenem, outcomesModule primaryOutcomes measure: Percentage of Participants With Clinical Response of Clinical Cure at the End-of-Therapy (EOT) Visit in the Intent-to-Treat (ITT) Population, secondaryOutcomes measure: Percentage of Participants With Clinical Response of Clinical Cure at the End-of-Therapy (EOT) Visit in the Microbiological Intent-to-Treat (mITT) Population, secondaryOutcomes measure: Percentage of Participants With Clinical Response of Clinical Cure at the Test-of-Cure (TOC) Visit in the Intent-to-Treat (ITT) Population, secondaryOutcomes measure: Incidence of microbiologically documented infections and identification of causative organisms in culture, secondaryOutcomes measure: In-hospital mortality, secondaryOutcomes measure: Occurrence of graft versus host disease (GVHD), secondaryOutcomes measure: Frequency of multidrug resistant-pathogen infections or colonization, secondaryOutcomes measure: Faecal microbiota analysis, secondaryOutcomes measure: Percentage of Participants Who Report 1 or More Adverse Event (AE), secondaryOutcomes measure: Percentage of Participants With Any Serious Adverse Event (SAE), secondaryOutcomes measure: Percentage of Participants Discontinuing Study Drug Due to an Adverse Event (AE), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: A Beneficência Portuguesa de São Paulo, city: São Paulo, country: Brazil, contacts name: João Prats, MD, role: CONTACT, phone: +55 11 3505 5031, geoPoint lat: -23.5475, lon: -46.63611, hasResults: False