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New blood test could slash unnecessary antibiotics in fragile newborns

NCT ID NCT06058819

Diagnosis Sponsor: Hospices Civils de Lyon 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study is testing whether a set of blood markers can accurately rule out late-onset sepsis in newborns in intensive care. Researchers will enroll 358 babies with signs of infection and compare the markers against a panel of experts. If the markers work well, doctors could avoid giving antibiotics to babies who don't need them, reducing resistance and side effects.

What this could mean

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

Active substance
blood biomarkers (IL6, IL10, NGAL, PCT, PTX3)
What this could lead to
If successful, this could give doctors a reliable way to quickly rule out sepsis in newborns, cutting down on unnecessary antibiotics and their side effects.
What could go wrong
This is a validation study, not a treatment trial. The biomarkers may not perform as well in this larger group, and the results may not change practice immediately.

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 358 people

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

Started

Nov 2023

Expected to finish

May 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.

Who is studied

Newborns aged ≥ 7 days hospitalized in one of the 2 neonatal intensive care units (Nantes or Lyon) for whom an infection is suspected.

Ages

7 to 14 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: * Patient hospitalized in the NICU of one of the two recruiting centers at the time of inclusion * Patients aged ≥ 7 days * Patients weighted ≥ 500 g the day of blood sample * patients with suggestive signs of LOS including at least one of the following:Fever \> 38°C; tachycardia \> 160bpm; capillary refill time \> 3 seconds; grey and/or pale skin complexion; apnea/ bradycardia syndrome, bloating; vomiting; rectal bleeding; hypotonia; lethargy; seizures without other obvious cause; increased ventilatory support and/or increased FiO2; cutaneous rash; inflammation at the needle-puncture site of the central venous catheter; or any other condition for which the clinician suspected an infection * patients with a standard of care blood sampling, including at least a blood culture; Exclusion Criteria: * Patient treated with antibiotics for a bacteriologically confirmed infection at the time of sampling or within 48 hours prior to sampling * Patient who underwent surgery within the previous 7 days * Patients vaccinated within the previous 7 days * Patient who received treatment with systemic corticosteroid therapy in the 48 hours prior to sampling * Patient with severe combined immunodeficiency * Opposition from parent(s)/guardian(s)

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Conditions

The condition(s) this trial relates to.

disease neonatal sepsis

As listed by the trial registrant

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

Neonatal late onset sepsis

How to take part

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

  1. The places running it

    3 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

  • Hôpital Couple-Enfant - CHU Grenoble Alpes

    RECRUITING

    Grenoble, 38700, France

  • Neonatal intensive care unit, Hôpital femme-maternité

    RECRUITING

    Nantes, 44300, France

  • neonatal Intensive care unit, Hôpital Femme Mère Enfant, Hospices Civils de Lyon, France

    RECRUITING

    Bron, 69500, France