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Could shorter antibiotics work just as well for newborns?

NCT ID NCT05329701

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether giving antibiotics for a shorter, personalized time is as safe and effective as the usual 7-day course for full-term newborns with a suspected infection. About 488 babies took part across 18 hospitals. The goal was to see if shorter treatment could reduce antibiotic use without increasing the risk of readmission or death.

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

488 people

The number who actually took part.

Started

Apr 2022

Finished

Aug 2025

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

1 hour to 72 hours

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: * Gestational age ≥ 35 weeks * Birth weight ≥ 2000 * Probable or possible infection according to the structured infection risk assessment * Sufficient size blood culture, preferably 0.5-1 ml, but at least 0.2 ml, drawn after onset of symptoms but before start of antibiotic treatment * Negative blood culture after 48 hours Exclusion Criteria: * Infants with positive blood culture * Blood culture volume prior to antibiotics of \< 0.2 ml * Site-specific infection as for example, meningitis or osteomyelitis * Infant fulfill current recommendation to stop antibiotic treatment at 36-48 hours; Low suspicion of sepsis initially including few and vague symptoms, CRP maximum 35-50 mg/l, negative blood culture and no symptoms after 48 hours of treatment

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Conditions

The condition(s) this trial relates to.

Infections neonatal sepsis

As listed by the trial registrant

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

Antibiotic side effect Early-onset neonatal sepsis

Contacts and locations

Locations

  • Ulrikka Nygaard

    Copenhagen, 2100, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.