Febrile Infants Swedish Study
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 guidelin
| Condition(s) | Febrile Illness Acute, Meningitis, Bacterial, Urinary Tract Infection (Diagnosis), Invasive Bacterial Infection, Serious Bacterial Infection, Bacteremia, Sepsis |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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. The 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 eligib |
| Who can participate | Inclusion Criteria: * Temperature ≥38.0 C (measured either at home or at the pediatric emergency department) * Age ≤60 days |
| Ages | 60 Days |
| Sex | All |
| Lead sponsor | Region Skane |
| Locations | Gothenburg, Sweden; Helsingborg, Sweden; Jönköping, Sweden; Kristianstad, Sweden; Lund, Sweden; Malmö, Sweden (+5 more sites) |
| Start date | 2025-12-01 |
| NCT ID | NCT07134751 |
| Official listing | https://clinicaltrials.gov/study/NCT07134751 |