New care guideline for infants 60 days and younger with fever in Sweden
Official title: Febrile Infants Swedish Study
Run by Region Skane · NCT07134751 · Data updated 2026-11-12
This project will test a new guideline to see if infants 60 days or younger with fever can safely avoid many invasive tests, hospital stays, and broad antibiotics compared with usual care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 60 Days |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | Region Skane Academic / other |
| Locations | 11 sites (Gothenburg and 10 other locations) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | September 30, 2028 |
| Registry record updated | April 2, 2026 |
| Trial ID | NCT07134751 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are infants aged 60 days or younger who present with a fever of at least 38.0°C to one of the participating pediatric emergency departments in Sweden.
✕Probably not a fit
Infants who already have clear signs of serious bacterial infection, are older than 60 days, or present to non-participating hospitals are unlikely to gain benefit from this guideline.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational implementation across 11 pediatric emergency departments in Sweden. Seven sites will introduce a new clinical guideline for fever without source in infants ≤60 days, while four sites will continue standard practice to provide a comparison. All febrile infants aged ≤60 days presenting with temperature ≥38.0°C are eligible and will be followed for diagnostic testing, hospital admissions, antibiotic use, and missed invasive bacterial infections. The design aims to measure real-world safety, resource use, and potential reductions in unnecessary care.
Why it matters
Potential benefit: If successful, the guideline could reduce unnecessary procedures, hospital admissions, and early antibiotic exposure for many young infants with fever.
How similar studies have gone: Previous research shows that risk-stratified algorithms can reduce testing and antibiotic use in some infant groups, but large multicenter implementations of a new guideline like this are relatively untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Temperature ≥38.0 C (measured either at home or at the pediatric emergency department) * Age ≤60 days
Where it's running
-
Sahlgrenska University Hospital
Gothenburg, Sweden Recruiting -
Ryhov County Hospital
Jönköping, Sweden Recruiting -
Kristianstad Central Hospital
Kristianstad, Sweden Recruiting -
Skåne University Hospital
Lund, Sweden Recruiting -
Skåne University Hospital
Malmö, Sweden Recruiting -
Örebro University Hospital
Örebro, Sweden Recruiting
Show 5 more locations
-
Karolinska University Hospital
Stockholm, Sweden Recruiting -
Uppsala University Hospital
Uppsala, Sweden Recruiting -
Ystad Hospital
Ystad, Sweden Recruiting -
Helsingborg Hospital
Helsingborg, Sweden Not yet recruiting -
Sachs' Children and Youth Hospital
Stockholm, Sweden Not yet recruiting
Study contacts
- Study coordinator: Ioannis Orfanos, Senior Consultant
- Email: ioannis.orfanos@med.lu.se
- Phone: +4646178225
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.