Febrile Infants Swedish Study

NCT07134751 | Recruiting

• 1 other identifier: Dnr 2024-05132-02
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 11

Brief 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

Conditions

Invasive Bacterial Infection; Serious Bacterial Infection; Bacteremia; Sepsis; Febrile Illness Acute; Meningitis, Bacterial; Urinary Tract Infection (Diagnosis)

Keywords

Guidelines; Febrile infants; Age ≤60 days; Management; Serious Bacterial Infections; Invansive Bacterial Infections; Clinical prediction tool

Outcome Measures

Primary Outcomes (1)

• The proportion of febrile infants aged ≤60 days with meningitis, bacteremia, and urinary tract infection identified by the new guideline and the proportion of those that received treatment with delay.

  10 days of attendance

Secondary Outcomes (3)

• The proportion of investigations, antibiotic treatments, and hospitalizations among febrile infants aged ≤60 days who visited the PED.

  Day 1

• The prevalence of meningitis, bacteremia, and urinary tract infection among febrile infants aged ≤60 days.

  10 days of attendance

• Duration and height of the fever, gestational age, birth weight, breastfeeding, clinical signs and symptoms, and laboratory results.

  Day 1

Study Arms (1)

Febrile Infants aged ≤60 days

Febrile Infants aged ≤60 days who present to the pediatric emergency department

Eligibility Criteria

• Age: Up to 60 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All febrile infants aged ≤60 days brought to any of the study Pediatric Emergency Departments will be considered eligible for the study.

You may qualify if:

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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (11)

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

Malmo, 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

MeSH Terms

Conditions

Meningitis, Bacterial; Urinary Tract Infections; Disease; Bacteremia; Sepsis

Condition Hierarchy (Ancestors)

Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Systemic Inflammatory Response Syndrome; Inflammation

Central Study Contacts

Ioannis Orfanos, Senior Consultant

CONTACT

+4646178225; ioannis.orfanos@med.lu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Senior Consultant Pediatrician

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 21, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: April 2, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 2 years and ending 4 years after the publication of results

Locations

SE (11)