[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621554":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":47,"responsibleParty":64,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":41,"enrollmentInfo":81,"targetDuration":41,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":93,"overallStatus":50,"whyStopped":41,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Humanitas University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care","ACTIVE_COMPARATOR","Standard of care antibiotic therapy with a suggested minimum duration of 10 days.",[13],"Other: Standard of Care Antibiotic Duration",{"label":15,"type":16,"description":17,"interventionNames":18},"Personalized Duration","EXPERIMENTAL","Patients in this arm will receive antibiotic therapy for a duration guided by clinical stability. Antibiotics will be discontinued after 72 consecutive hours of clinical stability, defined as apyrexia (Tc \\\u003C 38°C) for at least 48 hours and stable or improved qSOFA score.",[19],"Other: Clinical Stability-Driven Antibiotic Discontinuation Strategy",[21,27],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Clinical Stability-Driven Antibiotic Discontinuation Strategy","A therapeutic strategy where the duration of antibiotic treatment for Gram-negative bacteraemia is determined by the achievement of clinical stability (defined as apyrexia for 48h and stable\u002Fimproved qSOFA score) maintained for 72 consecutive hours",[15],[26],"A",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Standard of Care Antibiotic Duration","This intervention follows the standard clinical practice for treating Gram-negative bacteraemia in hematological patients. The duration of therapy is not fixed by a stability-driven rule but is based on the treating physician's decision, with a suggested minimum of 10 days.",[9],[32],"B",[34],{"name":35,"affiliation":5,"role":36},"Valeria Cento, MD, PhD","PRINCIPAL_INVESTIGATOR",[38,43],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","0282243166",null,"valeria.cento@hunimed.eu",{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},"Michele Bartoletti, MD, PhD","0282243568","michele.bartoletti@hunimed.eu",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Microbiology and Virology - IRCCS Humanitas Research Hospital","RECRUITING","Rozzano","Milan","20089","Italy","IT",{"type":57,"coordinates":58},"Point",[59,60],9.1559,45.38193,{"lat":60,"lon":59},[63],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},{"type":36,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Valeria Cento","Director of the Operative Unit of Microbiology and Virology",[68],{"name":69,"class":70},"Ministry of education, university and research, Italy","UNKNOWN","100621554","antibiotic-duration-and-outcomes-in-high-risk-febrile-neutropenia-patients-100621554",false,"NCT07372131","Antibiotic Duration and Outcomes in High-Risk Febrile Neutropenia Patients","Appropriate Management of Bacteriemic Febrile Neutropenia in High-Risk Hematological Patients. Relationship Between Duration of Antibiotic Administration, Outcome and Resistance Profile","PERaSTrA","Inclusion Criteria:\n\n* Diagnosed with a hematologic malignancy that is candidate for treatment with chemotherapy or bone marrow transplantation or chimeric antigen receptor T cell therapy (CAR-T)\n* Diagnosis of febrile neutropenia defined according to the guidelines of the Infectious Disease Society of America, IDSA; ref: Freifeld, A.G., et al., Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 update by the infectious diseases society of america. Clin Infect Dis, 2011. 52(4): p. e56-93.) as: Fever: single record of oral temperature \\>=38.3°C or a temperature \\>=38.0°C sustained over a period of one hour; Neutropenia: absolute neutrophil count \\\u003C 1000 cells\u002FmicroL; Expected duration of neutropenia \\>= 7 days\n* Diagnosis of bacteraemia defined by positive blood cultures (at least 1 vial positive for a non-contaminating microorganism)\n* Isolation of Gram-Negative species\n\nExclusion Criteria:\n\n* Contextual diagnosis of pneumonia\n* Contextual diagnosis of intra-abdominal infection, in particular: neutropenic enterocolitis\u002Ftyphlitis or biliary tract infection\n* Persistently positive blood cultures at randomization\n* Any condition that endangers the safety of the patient based on the judgment of the treating physician","ALL","18 Years",{"count":82,"type":83},172,"ESTIMATED","INTERVENTIONAL",[86],"NA","The goal of this clinical trial is to learn if a personalized duration of antibiotic therapy, based on clinical stability, is as effective as a standard duration of at least 10 days in hospitalized patients with hematologic malignancies (such as leukemia or lymphoma) who develop febrile neutropenia and Gram-negative bacteraemia.\n\nThe main questions it aims to answer are:\n\n* Can a personalized antibiotic duration increase the number of days free from anti-Gram-negative therapy within 28 days without compromising patient safety?\n* How does the duration of antibiotic therapy (short vs. prolonged) affect the rate and modality of gut microbiota reconstitution?\n\nResearchers will compare:\n\n* Group A (Personalized Duration): Antibiotics are stopped after the patient maintains clinical stability (no fever and stable vital signs) for 72 consecutive hours.\n* Group B (Standard of Care): Antibiotics are continued for a standard duration, typically at least 10 days, based on current clinical surveys and physician decision.\n\nParticipants will:\n\n* Be randomized to receive either the personalized or the standard duration of antibiotic therapy once a Gram-negative infection is confirmed in the blood.\n* Be monitored for 28 days to assess for new fever episodes, recurrence of infection, and overall survival.\n* If participating in the microbiological sub-study, provide biological samples (blood, feces, and rectal swabs) at specific time points (at the onset of fever, at the end of treatment, and at day 28).\n* Undergo specialized laboratory testing (Whole Metagenomic Sequencing) on the collected samples to evaluate the evolution of their intestinal and blood microbiota and the presence of antibiotic-resistant genes.",[89,90,91,92],"Bloodstream Infection","Gram Negative Infections","Bacteraemia Caused by Gram-Negative Bacteria","Febrile Neutropenia (FN)",[94,89,95,96],"Antibiotics","Hematological patients with febrile neutropenia","Gram-negative","2026-01-20",{"date":99,"type":100},"2026-01-28","ACTUAL",{"date":102,"type":100},"2025-05-10",{"date":104,"type":83},"2026-11-30",{"name":5,"class":6},1]