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Hospital","Ystad",{"type":25,"coordinates":149},[150,151],13.82041,55.42966,{"lat":151,"lon":150},[154,156],{"name":155,"role":15,"phone":10,"phoneExt":10,"email":10},"Madeleine Touma, MD",{"name":155,"role":34,"phone":10,"phoneExt":10,"email":10},{"type":34,"investigatorFullName":158,"investigatorTitle":159,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Orfanos Ioannis","MD, PhD, Senior Consultant Pediatrician","100603302",false,"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","ALL","60 Days",{"count":169,"type":170},2000,"ESTIMATED","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",[174,175,176,177,178,179,180],"Febrile Illness Acute","Meningitis, Bacterial","Urinary Tract Infection (Diagnosis)","Invasive Bacterial Infection","Serious Bacterial Infection","Bacteremia","Sepsis",[182,183,184,185,186,187,188],"Guidelines","Febrile infants","Age ≤60 days","Management","Serious Bacterial Infections","Invansive Bacterial Infections","Clinical prediction tool","2026-04-01",{"date":191,"type":192},"2026-04-02","ACTUAL",{"date":194,"type":192},"2025-12-01",{"date":196,"type":170},"2028-09-30",{"name":5,"class":6},11]