[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"invasive-bacterial-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:invasive-bacterial-infection":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,54,92,116],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":5},"100639005","phase-4-early-discontinuation-of-antibiotics-in-paediatric-high-risk-febrile-neutropenia-100639005",false,"NCT07590648","Early Discontinuation of Antibiotics in Paediatric High-risk Febrile Neutropenia","Phase IV, Randomized, Open Label, Parallel Groups Clinical Trial for Evaluating the Early Stop of Antibiotic Treatment in High-risk Febrile Neutropenic Oncohaematological Paediatric Patients (e-STOP 2)","E-STOP2","Inclusion Criteria:\n\n1. Male and female patients ≤18 years of age expected to develop prolonged neutropenia (\\>7 days), with:\n\n   * Acute myeloblastic leukaemia at any phase of chemotherapy\n   * Acute lymphoblastic leukaemia in induction, consolidation, or intensification phases\n   * Biphenotypic leukaemia at any phase of chemotherapy\n   * Lymphoblastic lymphoma in induction and consolidation phases\n   * B-cell and anaplastic lymphoma receiving high-intensity chemotherapy\n   * Solid tumours receiving high-intensity chemotherapy\n   * Relapsed leukaemia at any phase of treatment\n2. Episode of febrile neutropenia (FN), defined as a single axillary temperature ≥38.0°C in a patient with an absolute neutrophil count (ANC) \\\u003C500 neutrophils\u002Fmm³, or expected to fall below this value within the next 48-72 hours.\n3. Antibiotic treatment initiated for the current FN episode (routine antimicrobial prophylaxis is allowed, as well as teicoplanin 3 days\u002Fweek for patients with AML included in the CHIP-AML-2022 protocol and therefore in the Pro-teico study).\n4. Low risk of invasive bacterial infection (IBI) at the start of the FN episode. Patients must meet all of the following:\n\n   * CRP \\\u003C9 mg\u002FdL\n   * PCT \\\u003C0.5 ng\u002FmL\n   * Absence of hypotension\n5. No microbiologically documented bacterial infection 48-72 hours after the FN episode.\n6. Good clinical evolution 48-72 hours after the FN episode, defined as:\n\n   * Afebrile for \\>48 hours (axillary temperature \\\u003C38°C)\n   * Haemodynamically stable\n   * Stable paediatric early warning score (PEWS)\n7. CRP \\\u003C5 mg\u002FdL, or CRP \\\u003C9 mg\u002FdL and PCT \\\u003C0.5 ng\u002FmL, with decreasing trend at the time of randomisation (values will be assessed on day 3 and day 5 after the FN episode).\n8. ANC \\\u003C500 neutrophils\u002Fmm³ at the time of randomisation.\n9. Signed informed consent from the patient and\u002For parent(s)\u002Flegal representative(s).\n10. Patient and\u002For parent(s)\u002Flegal representative(s) must have sufficient reading and writing skills to understand and provide consent to participate in the study.\n11. Patient and\u002For parent(s)\u002Flegal representative(s) must be considered reliable and capable of adhering to the protocol.\n\nExclusion Criteria:\n\n1. Antibiotic treatment at the time of the FN episode different from that used prophylactically.\n2. Empirical antibiotic treatment different from that recommended in international guidelines.\n3. Patient with poor clinical evolution during the first 12 hours (hemodynamic instability, PICU admission, death).\n4. Active participation in the same study at the onset of the current FN episode.\n5. Active participation in another clinical trial that, in the investigators' opinion, may interfere with the assessment of the results.\n6. Any condition which, in the investigator's opinion, makes study participation unsuitable for the patient or could limit, prevent, or confound the assessments planned in the protocol.\n7. Female patients who are pregnant or breastfeeding","ALL","18 Years",{"count":20,"type":21},136,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The goal of this clinical trial is to evaluate whether stopping antibiotic treatment early is safe in paediatric patients with cancer who develop high-risk febrile neutropenia but show good clinical evolution and low biomarker levels 48-72 hours after the episode.\n\nThe main questions it aims to answer are:\n\nIs early discontinuation of antibiotics as safe as the standard strategy in terms of preventing invasive bacterial infections (such as sepsis, microbiologically documented infection, ICU admission, or death)? Does this strategy reduce the number of days on antibiotics without increasing infection-related complications?\n\nResearchers will compare early antibiotic discontinuation with the standard care strategy to see whether the early-stop approach provides similar safety while reducing antibiotic exposure.\n\nParticipants will:\n\nReceive standard initial antibiotic therapy for febrile neutropenia. Undergo clinical and biomarker evaluations (including CRP and PCT).\n\nBe randomly assigned to:\n\nExperimental group: early discontinuation of antibiotics, or Control group: continuation of the standard antibiotic strategy.\n\nBe followed for 28 days after randomisation to monitor safety outcomes and treatment effects.",[27,28,29,30,31],"Febrile Neutropenia (FN)","Pediatric Cancer","Hematologic Malignancies","Solid Tumors","Invasive Bacterial Infection",[33,34,29,30,31,35,36,37,38,39,40,41],"Febrile Neutropenia","Pediatric Oncology","Antibiotic Discontinuation","Antibiotic Stewardship","Biomarkers (CRP, PCT, IL-8)","Early Stop Strategy","Randomized Clinical Trial","Non-Inferiority Trial","Neutropenia","NOT_YET_RECRUITING","2026-05-13",{"date":45,"type":46},"2026-05-15","ACTUAL",{"date":48,"type":21},"2026-06-01",{"date":50,"type":21},"2028-07-01",{"name":52,"class":53},"Hospital Universitari Vall d'Hebron Research Institute","OTHER",{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":65,"conditions":66,"keywords":73,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100603302","febrile-infants-swedish-study-100603302","NCT07134751","Febrile Infants Swedish Study","FISS","Inclusion Criteria:\n\n* Temperature ≥38.0 C (measured either at home or at the pediatric emergency department)\n* Age ≤60 days","60 Days",{"count":63,"type":21},2000,"OBSERVATIONAL","Approximately one million febrile infants aged ≤60 days present annually to pediatric emergency departments (PEDs) in Europe and the United States. Although fewer than 5% are diagnosed with meningitis or bacteremia (invasive bacterial infections - IBIs), and 10-15% with urinary tract infections (UTIs), current guidelines recommend extensive diagnostic evaluations, hospitalization, and empirical treatment with broad-spectrum parenteral antibiotics. This approach may contribute to medical overuse, with implications for patient care, healthcare resource utilization, and environmental sustainability.\n\nThe Febrile Infants Swedish Study (FISS) is a prospective observational study conducted across 11 PEDs in Sweden. All febrile infants aged ≤60 days presenting to participating sites will be eligible. A new clinical guideline for the management of infants with fever without source (FWS) will be implemented in 7 PEDs, while 4 PEDs will continue with current standard practice and serve as a comparison group.\n\nThe study is expected to run for approximately two years and aims to recruit a minimum of 2,500 febrile infants",[67,68,69,31,70,71,72],"Febrile Illness Acute","Meningitis, Bacterial","Urinary Tract Infection (Diagnosis)","Serious Bacterial Infection","Bacteremia","Sepsis",[74,75,76,77,78,79,80],"Guidelines","Febrile infants","Age ≤60 days","Management","Serious Bacterial Infections","Invansive Bacterial Infections","Clinical prediction tool","RECRUITING","2026-04-01",{"date":84,"type":46},"2026-04-02",{"date":86,"type":46},"2025-12-01",{"date":88,"type":21},"2028-09-30",{"name":90,"class":53},"Region Skane",11,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":100,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100536093","communautary-pediatric-bacterial-infection-in-intensive-care-unit-100536093","NCT06260345","CommunautAry Pediatric bacteRial Infection in Intensive CarE Unit","Observatory of Pediatric Severe Communautary Bacterial Infections","CAPRICE","Inclusion Criteria:\n\n* Age \\\u003C18 years (only hospitalized children)\n* Severe communautary bacterial infection defined by hospitalization in a pediatric intensive care unit (documentation of infection by identification of the bacteria in a sterile environment).\n\nExclusion Criteria:\n\n* Refusal by one of the parents or by Child in understanding age\n* Nosocomial infection",{"count":101,"type":21},3000,"Severe bacterial infections are a worldwide scourge. However, the epidemiology of this type of infection varies over time. It is therefore essential to monitor them in order to prevent them more effectively. At this time, in France, no monitoring exists for this kind of infections.",[104,105,31],"Hospitalized Children","Severe Infection","2026-03-17",{"date":108,"type":46},"2026-03-19",{"date":110,"type":46},"2024-01-01",{"date":112,"type":21},"2030-01-01",{"name":114,"class":53},"Association Clinique Thérapeutique Infantile du val de Marne",1,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":125,"conditions":126,"keywords":132,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":4},"100533019","path-study-people-with-injecting-related-infections-assessing-treatment-outcomes-for-those-who-are-hospitalised-100533019","NCT06220370","PATH Study: People With Injecting Related Infections: Assessing Treatment Outcomes for Those Who Are Hospitalised.","PATH","Inclusion Criteria:\n\n1. Have voluntarily signed the informed consent form,\n2. 18 years of age or older,\n3. Injected drugs within the last 6 months,\n4. Admitted to hospital with invasive bacterial or fungal infection, a. Examples of invasive infection include: bloodstream infection, bone and joint infection (osteomyelitis, septic arthritis, discitis), central nervous system infection (epidural abscess, meningitis), deep abscess (i.e., brain, liver, muscle, spleen), endovascular infection (infective endocarditis, septic thrombophlebitis, mycotic aneurysm, septic embolism), skin or soft tissue infection (necrotising fasciitis, myositis),\n\nExclusion Criteria:\n\n1\\) Is unable or unwilling to provide informed consent or abide by the requirements of the study.",{"count":124,"type":21},300,"We seek to characterise the burden and outcomes of and understand the current experience of people who inject drugs admitted to hospital with invasive injecting-related infections, in order to implement and evaluate strategies to improve completion of therapy and reduce patient-directed discharges, with ultimate benefit to the patient and health service.",[127,31,128,129,130,131],"Invasive Fungal Infections","Injection Site Infection","Infection, Bacterial","Infection, Fungal","Infection, Soft Tissue",[133,134,135],"Antimicrobial therapy","Patient-directed discharge","Injection-related infectious diseases","2024-02-18",{"date":138,"type":46},"2024-02-20",{"date":140,"type":21},"2024-03-01",{"date":142,"type":21},"2029-03-01",{"name":144,"class":145},"Kirby Institute","OTHER_GOV"]