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Can kids with blood infections skip the IV earlier?

NCT ID NCT07791914

Disease control Sponsor: Ulrikka Nygaard Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests whether children and teens with uncomplicated bloodstream infections can safely switch from intravenous (IV) antibiotics to oral antibiotics earlier than usual. Half the participants will switch to oral antibiotics as soon as they are stable, within 4 days of starting IV treatment. The other half will continue IV therapy for at least 5 days. Researchers will compare how often the infection fails to clear or comes back in each group.

What this could mean

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

Active substance
oral antibiotic therapy
What this could lead to
If early oral switch works as well as IV therapy, children could go home sooner with fewer needle-related risks and less hospital time.
What could go wrong
This is a phase 4 trial with 150 participants, so results may not apply to all children. There is a risk that oral antibiotics might not fully clear the infection, leading to relapse.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 150 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

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.

Ages

4 weeks to 17 years

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 1. Age 4 weeks to 17 years 2. Positive blood culture with a i) pathogenic bacterium (eg, Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacterales, Fusobacterium spp. and other pathogenic bacteria) or ii) preliminary blood culture result (eg, Gram-negative rods or Gram-positive cocci in clusters/chains) judged by the investigator to be clinically relevant (ie, not a contaminant) and for which IV antibiotic therapy would be indicated according to standard guidelines 3. Clinical stability, defined as: (a) respiratory and haemodynamic stability, without need for oxygen, IV fluid therapy or inotropic support; and (b) well-appearing with signs of clinical improvement (eg, improved physical activity), as judged by the investigator 4. Tolerating oral fluids and diet, as judged by the investigator 5. Within the randomization window (see below) 6. Informed consent obtained from a parent or guardian, and from the patient if aged 15 years or older Randomization window: Randomization will take place (1) as soon as possible after eligibility is confirmed, and (2) before completion of a maximum of 4 days (96 hours) of effective IV antibiotic therapy, including the duration of the last IV dose (eg, 8 hours for penicillin and 24 hours for ceftriaxone) EXCLUSION CRITERIA 1. Complicated infections: a. Suspicion of endocarditis (echocardiography not performed routinely), b. Suspicion of CNS infection or post-septal cellulitis, c. Foreign material (eg, bone infection involving prosthetic material). d. Complicated postoperative course (eg, perforated appendicitis) 2. Blood culture positive with a. Neisseria meningitidis, b. Streptococcus pneumoniae if afebrile within 24 hours of blood culture collection, c. bacteria considered possible contaminants (eg, coagulase-negative staphylococci, Corynebacterium spp., Micrococcus spp.) 3. Premature infants with a corrected age of less than 28 days 4. No available suitable oral antibiotic (eg, due to antimicrobial resistance or contraindications) 5. Known chronic disease associated with an increased risk of severe infection: i) Immunosuppression, e.g., chemotherapy or biological therapy predisposing to severe infections, ii) Permanent central venous catheter due to an underlying condition, iii) Severe urinary tract abnormalities predisposing to bacteremia, including children receiving prophylactic antibiotic treatment.

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Conditions

The condition(s) this trial relates to.

bacterial infectious disease with sepsis Sepsis

As listed by the trial registrant

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

Bacteremia sepsis Bloodstream infection

How to take part

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

  1. The places running it

    18 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

  • Aarhus University Hospital

    Aarhus, Denmark

  • Copenhagen University Hospital, Rigshospitalet

    Copenhagen, 2100, Denmark

  • Department of Paediatrics and adolescent medicine, NIDO Danmark, Gødstrup Hospital

    Gødstrup, Denmark

  • Department of Pediatrics, Aabenraa Hospital

    Aabenraa, Denmark

  • Department of Pediatrics, Aalborg University Hospital

    Aalborg, Denmark

  • Department of Pediatrics, Esbjerg Hospital

    Esbjerg, Denmark

  • Department of Pediatrics, Herlev Hospital

    Herlev, Denmark

  • Department of Pediatrics, Hillerød Hospital

    Hillerød, Denmark

  • Department of Pediatrics, Hjørring Hospital

    Hjørring, Denmark

  • Department of Pediatrics, Holbæk Hospital

    Holbæk, Denmark

  • Department of Pediatrics, Hvidovre Hospital

    Hvidovre, Denmark

  • Department of Pediatrics, Kolding Hospital

    Kolding, Denmark

  • Department of Pediatrics, Nykøbing Falster Hospital

    Nykøbing Falster, Denmark

  • Department of Pediatrics, Randers Hospital

    Randers, Denmark

  • Department of Pediatrics, Roskilde University Hospital

    Roskilde, Denmark

  • Department of Pediatrics, Slagelse Hospital

    Slagelse, Denmark

  • Department of Pediatrics, Viborg Hospital

    Viborg, Denmark

  • Hans Christian Andersen Children's Hospital, Odense University Hospital

    Odense, Denmark

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