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Simple blood test could save babies from unnecessary antibiotics

NCT ID NCT06618989

Diagnosis Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This pilot study tests a new blood test that looks at markers on white blood cells to tell if a feverish baby under 3 months has a serious bacterial infection. Researchers will collect an extra small blood sample from 180 infants in the emergency department. The goal is to see if this test can accurately predict infection, helping doctors decide who truly needs antibiotics and who can go home safely.

What this could mean

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

Active substance
Blood test measuring leukocyte cell surface markers
What this could lead to
If successful, this blood test could help doctors quickly identify which febrile infants need antibiotics and which do not, reducing unnecessary hospital stays and treatments.
What could go wrong
This is a small pilot study with only 180 infants, so results may not be definitive. The test is still experimental and may not work as well in real-world settings.

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 180 people

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

Started

Feb 2025

Expected to finish

Sep 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

All infants aged between 7 and 90 days presenting to emergency departments with fever.

Ages

7 to 90 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: * Children aged between 7 and 90 days * Visiting the emergency department with fever (Temperature greater than or equal to 38° measured rectally in the emergency department or reported by parents) OR whose fever is detected during the emergency department visit (Temperature greater than or equal to 38° measured rectally in the emergency department) * Consent signed by one of the two parents/guardians Exclusion Criteria: * Weight less than 2,500 grams * Chronic illness (heart failure...) * Known immune deficiency * Congenital anomaly significantly modifying the probability of bacterial infection (pulmonary malformation, esophageal atresia...) * Antibiotic therapy in the previous 48 hours * Clinically evident source of fever: skin infection, joint infection, etc. * Parents or guardians unable to understand French * Non-affiliation with a social security scheme (including AME)

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Conditions

The condition(s) this trial relates to.

bacterial infectious disease disease Fever

As listed by the trial registrant

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

Children under 3 months of age with fever

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. 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

  • Sorbonne University, pediatric emergency department, Trousseau hospital

    RECRUITING

    Paris, France, 75012, France

  • hospitalpediatric emergency department, Trousseau hospital

    NOT_YET_RECRUITING

    Paris, 75012, France