Actively Recruiting
Febrile Infants Swedish Study
Led by Region Skane · Updated on 2026-04-02
2000
Participants Needed
11
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Febrile Infants Swedish Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Temperature 38.0 C measured either at home or at the pediatric emergency department
- Age 60 days
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Sahlgrenska University Hospital
Gothenburg, Sweden
Actively Recruiting
2
Helsingborg Hospital
Helsingborg, Sweden
Not Yet Recruiting
3
Ryhov County Hospital
Jönköping, Sweden
Actively Recruiting
4
Kristianstad Central Hospital
Kristianstad, Sweden
Actively Recruiting
5
Skåne University Hospital
Lund, Sweden
Actively Recruiting
6
Skåne University Hospital
Malmö, Sweden
Actively Recruiting
7
Örebro University Hospital
Örebro, Sweden
Actively Recruiting
8
Karolinska University Hospital
Stockholm, Sweden
Actively Recruiting
9
Sachs' Children and Youth Hospital
Stockholm, Sweden
Not Yet Recruiting
10
Uppsala University Hospital
Uppsala, Sweden
Actively Recruiting
11
Ystad Hospital
Ystad, Sweden
Actively Recruiting
Research Team
I
Ioannis Orfanos, Senior Consultant
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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