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New guidelines aim to cut unnecessary antibiotics in febrile babies

NCT ID NCT07134751

Knowledge-focused Sponsor: Region Skane Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether a new, simpler guideline can safely reduce the number of tests, antibiotics, and hospital stays for infants under 2 months old with a fever. Researchers will compare hospitals using the new guideline to those using standard care. The goal is to find out if the new approach can identify serious infections without overtreating the many infants who are not seriously ill.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to safer, more efficient care for febrile infants, reducing hospital stays and antibiotic overuse.
What could go wrong
This is an observational study, not a treatment trial. The new guideline may not prove safer or more effective than current practice, and results may not apply outside Sweden.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

Up to 60 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Temperature ≥38.0 C (measured either at home or at the pediatric emergency department) * Age ≤60 days

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Conditions

The condition(s) this trial relates to.

bacterial infectious disease bacterial infectious disease with sepsis bacterial meningitis disease infectious disease with sepsis Sepsis urinary tract infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bacteremia Febrile illness acute Invasive bacterial infection Meningitis, bacterial Sepsis Serious bacterial infection Urinary tract infection (diagnosis)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Helsingborg Hospital

    NOT_YET_RECRUITING

    Helsingborg, Sweden

  • Karolinska University Hospital

    RECRUITING

    Stockholm, Sweden

  • Kristianstad Central Hospital

    RECRUITING

    Kristianstad, Sweden

  • Ryhov County Hospital

    RECRUITING

    Jönköping, Sweden

  • Sachs' Children and Youth Hospital

    NOT_YET_RECRUITING

    Stockholm, Sweden

  • Sahlgrenska University Hospital

    RECRUITING

    Gothenburg, Sweden

  • Skåne University Hospital

    RECRUITING

    Lund, Sweden

  • Skåne University Hospital

    RECRUITING

    Malmö, Sweden

  • Uppsala University Hospital

    RECRUITING

    Uppsala, Sweden

  • Ystad Hospital

    RECRUITING

    Ystad, Sweden

  • Örebro University Hospital

    RECRUITING

    Örebro, Sweden

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