[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bacteraemia-caused-by-gram-negative-bacteria\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bacteraemia-caused-by-gram-negative-bacteria":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"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":20,"type":21},172,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30],"Bloodstream Infection","Gram Negative Infections","Bacteraemia Caused by Gram-Negative Bacteria","Febrile Neutropenia (FN)",[32,27,33,34],"Antibiotics","Hematological patients with febrile neutropenia","Gram-negative","RECRUITING","2026-01-20",{"date":38,"type":39},"2026-01-28","ACTUAL",{"date":41,"type":39},"2025-05-10",{"date":43,"type":21},"2026-11-30",{"name":45,"class":46},"Humanitas University","OTHER"]