RecruitingNCT07134751

Febrile Infants Swedish Study


Sponsor

Region Skane

Enrollment

2,000 participants

Start Date

Dec 1, 2025

Study Type

OBSERVATIONAL

Conditions

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 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


Eligibility

Max Age: 60 Days

Inclusion Criteria2

  • Temperature ≥38.0 C (measured either at home or at the pediatric emergency department)
  • Age ≤60 days

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Locations(11)

Sahlgrenska University Hospital

Gothenburg, Sweden

Helsingborg Hospital

Helsingborg, Sweden

Ryhov County Hospital

Jönköping, Sweden

Kristianstad Central Hospital

Kristianstad, Sweden

Skåne University Hospital

Lund, Sweden

Skåne University Hospital

Malmo, Sweden

Örebro University Hospital

Örebro, Sweden

Karolinska University Hospital

Stockholm, Sweden

Sachs' Children and Youth Hospital

Stockholm, Sweden

Uppsala University Hospital

Uppsala, Sweden

Ystad Hospital

Ystad, Sweden

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NCT07134751


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