Condition: Febrile Illness Acute · Meningitis, Bacterial · Urinary Tract Infection (Diagnosis) · Sponsor: Region Skane
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 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. The study is expected to run for approximately two years and aims to recruit a minimum of 2,500 febrile infants
This description comes directly from the study's public registry record.
Ioannis Orfanos, Senior Consultant · +4646178225 · ioannis.orfanos@med.lu.se
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| Sahlgrenska University Hospital | Gothenburg, Sweden | Recruiting |
| Helsingborg Hospital | Helsingborg, Sweden | Not Yet Recruiting |
| Ryhov County Hospital | Jönköping, Sweden | Recruiting |
| Kristianstad Central Hospital | Kristianstad, Sweden | Recruiting |
| Skåne University Hospital | Lund, Sweden | Recruiting |
| Skåne University Hospital | Malmö, Sweden | Recruiting |
| Örebro University Hospital | Örebro, Sweden | Recruiting |
| Karolinska University Hospital | Stockholm, Sweden | Recruiting |
| Sachs' Children and Youth Hospital | Stockholm, Sweden | Not Yet Recruiting |
| Uppsala University Hospital | Uppsala, Sweden | Recruiting |
| Ystad Hospital | Ystad, Sweden | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07134751