Clinical trial Recruiting at 9 sites Observational Ages Any age to 60 Days

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.

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Quick facts

Study typeObservational
AgesAny age to 60 Days
SexAll
Enrollment2000 (estimated)
SponsorRegion Skane
Academic / other
Locations11 sites (Gothenburg and 10 other locations)
StatusRecruiting
StartedDecember 1, 2025
Main results expectedDecember 31, 2027
Study endsSeptember 30, 2028
Registry record updatedApril 2, 2026
Trial IDNCT07134751 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.