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New blood test could spot dangerous infections in feverish kids faster

NCT ID NCT03163628

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether a combination of 7 biomarkers in the blood can more accurately diagnose severe bacterial infections in children aged 7 days to 36 months with fever. Researchers enrolled 983 children and compared the biomarker panel's performance against standard tests like CRP and procalcitonin. The goal is to help doctors quickly tell apart bacterial from viral infections, reducing unnecessary antibiotic use.

What this could mean

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

Active substance
biomarker blood test (combination of 7 markers)
What this could lead to
If successful, this could lead to a more accurate blood test to quickly tell if a feverish child has a severe bacterial infection versus a viral one, reducing unnecessary antibiotics.
What could go wrong
This is a completed diagnostic study, not a treatment trial. The new test combination may not prove significantly better than existing tests like CRP or procalcitonin 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.

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

983 people

The number who actually took part.

Started

Jun 2017

Finished

Jun 2019

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

7 days to 36 months

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: * Febrile children: * Between 7 days and 3 months old : fever \>38°C for more than 6 hours (late neonatal fever suspected) for which the physician prescribed venipuncture * Between 3 months and 36 months old : fever ≥38,5°C for more than 6 hours and less than 7 days for which the physician prescribed venipuncture for suspected severe bacterial infection * Patient with national health cover * Consent form signed by at least one parent Exclusion Criteria: * Children treated by antibiotherapy within the past 48h * Children with congenital or acquired immunodeficiency syndrome or long-term immunosuppression treatment * Vaccinated children within 48h by an inactivated vaccine or within 10 days for the MMR vaccines * Children with a chronic disease * undergoing surgery within 7 days before inclusion

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Conditions

The condition(s) this trial relates to.

bacterial infectious disease disease viral infectious disease

As listed by the trial registrant

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

Infection viral Infection, bacterial

Contacts and locations

Locations

  • Hospices Civils de Lyon

    Bron, 69500, France

  • Hôpital Louis Mourier - APHP

    Colombes, 92700, France

  • Hôpital Nord Ouest

    Gleizé, 69655, France

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