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New blood test could spot sepsis in newborns faster

NCT ID NCT07670624

Diagnosis Sponsor: Salzburger Landeskliniken 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 10, 2026 · Updated 8 times

Summary

This study will test a new biomarker called t6A to see if it can help doctors diagnose bacterial infections in newborn babies early. Researchers will measure t6A levels in 210 infants who need blood tests for suspected infection. The goal is to find a more accurate way to detect sepsis, which could lead to quicker treatment and fewer unnecessary antibiotics.

What this could mean

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

Active substance
N6-threonylcarbamoyladenosine (t6A) biomarker test
What this could lead to
If successful, this could provide a faster, more accurate way to diagnose bacterial infections in newborns, potentially reducing unnecessary antibiotic use and improving outcomes.
What could go wrong
This is an early study with 210 participants and has not yet started recruiting. The biomarker may not prove reliable enough to replace current methods, and results may not apply to all newborns.

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 210 people

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

Started

Sep 2026

Expected to finish

Jan 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.

Who is studied

Newborn infants

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: * Newborn infants who require blood testing for screening for bacterial infection OR treating physician suspects bacterial infection in newborn infant * Signed informed consent form Exclusion Criteria: 1. Refusal to participate in study or not providing written informed consent by caregivers/parents 2. Antibiotic treatment of any kind.

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Conditions

The condition(s) this trial relates to.

infectious disease with sepsis neonatal sepsis Sepsis

As listed by the trial registrant

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

Biomarker discovery Newborn sepsis Sepsis

How to take part

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

  1. The places running it

    2 sites in 2 countries. 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

  • Paracelsus Medical Private University- University Hospital Salzburg Dept. of Pediatrics and Adolescent Medicine, Division of Neonatology

    RECRUITING

    Salzburg, 5020, Austria

  • Wroclaw Medical University

    NOT_YET_RECRUITING

    Wroclaw, 50367, Poland

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