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Blood test could spare thousands of preemies from unnecessary antibiotics

NCT ID NCT06100614

Diagnosis Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tests whether adding a quick blood test for presepsin can safely reduce unnecessary antibiotic use in very preterm infants. Currently, over 85% of these babies get antibiotics right after birth, but only 1 in 70 actually has an infection. The study will enroll 900 infants born before 32 weeks to see if the test cuts antibiotic use by at least 30% without increasing missed infections.

What this could mean

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

Active substance
Presepsin diagnostic test
What this could lead to
If successful, this test could help doctors avoid giving unnecessary antibiotics to many preterm infants, reducing side effects like bowel problems and allergies.
What could go wrong
The test might not be accurate enough, leading to missed infections or only a small reduction in antibiotic use. Results are from a single trial and need confirmation.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 900 people

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

Started

Sep 2024

Expected to finish

Jan 2027

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Infants born at a gestational age of 24+0 to 31 6/7 weeks * Moderate risk of early-onset neonatal sepsis, i.e. infants who should be treated with empirical antibiotics based on the Dutch EOS guideline. Exclusion Criteria: * low risk of early-onset neonatal sepsis who do not have an indication for empirical antibiotics according to the Dutch EOS guideline; * high risk of early-onset neonatal sepsis defined as: 1. suspected or confirmed diagnosis of maternal sepsis; 2. suspected or proven EOS in other infants (in case of multiple births) or infants born to mothers with previous infant with GBS disease/infection; 3. unexplained respiratory insufficiency requiring invasive mechanical ventilation and FiO2\>0.40 or non-invasive ventilation with FiO2 \>0.60 at time of randomization; 4. ongoing hemodynamic instability requiring inotrope medication or more than one 10 ml/kg fluid bolus at time of randomization; 5. strong clinical concern for sepsis due to physical exam findings (i.e. minimal responsiveness, poor tone).

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Conditions

The condition(s) this trial relates to.

neonatal sepsis

As listed by the trial registrant

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

Early-onset neonatal sepsis

How to take part

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

  1. The places running it

    1 site. 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

  • Amsterdam UMC

    RECRUITING

    Amsterdam, North Holland, 1105 AZ, Netherlands

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