| NCT ID | NCT07134751 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region Skane |
| Condition | Febrile Illness Acute |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2025-12-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
Inclusion Criteria: * Temperature ≥38.0 C (measured either at home or at the pediatric emergency department) * Age ≤60 days
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07134751 clinical trial?
This trial is open to participants of all sexes, up to 60 Days, studying Febrile Illness Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07134751 currently recruiting?
Yes, NCT07134751 is actively recruiting participants. Contact the research team at ioannis.orfanos@med.lu.se for enrollment information.
Where is the NCT07134751 trial being conducted?
This trial is being conducted at Gothenburg, Sweden, Helsingborg, Sweden, Jönköping, Sweden, Kristianstad, Sweden and 7 additional locations.
Who is sponsoring the NCT07134751 clinical trial?
NCT07134751 is sponsored by Region Skane. The trial plans to enroll 2,000 participants.