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Study identifier: NCT07134751 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Febrile Infants Swedish Study

Condition: Febrile Illness Acute · Meningitis, Bacterial · Urinary Tract Infection (Diagnosis)  ·  Sponsor: Region Skane

PhaseN/A
Planned participants2000
Who can joinAll sexes, N/A to 60 Days
Healthy volunteersNo

About this 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 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.

Talk to the study team

Ioannis Orfanos, Senior Consultant  ·  +4646178225  ·  ioannis.orfanos@med.lu.se

Always discuss trial participation with your own doctor first.

Locations (11)

Sahlgrenska University HospitalGothenburg, SwedenRecruiting
Helsingborg HospitalHelsingborg, SwedenNot Yet Recruiting
Ryhov County HospitalJönköping, SwedenRecruiting
Kristianstad Central HospitalKristianstad, SwedenRecruiting
Skåne University HospitalLund, SwedenRecruiting
Skåne University HospitalMalmö, SwedenRecruiting
Örebro University HospitalÖrebro, SwedenRecruiting
Karolinska University HospitalStockholm, SwedenRecruiting
Sachs' Children and Youth HospitalStockholm, SwedenNot Yet Recruiting
Uppsala University HospitalUppsala, SwedenRecruiting
Ystad HospitalYstad, SwedenRecruiting

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Source record: clinicaltrials.gov/study/NCT07134751