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Finger-Prick test could cut needless antibiotics in feverish toddlers

NCT ID NCT03607162

Diagnosis Sponsor: Nantes University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Young children who arrive at the emergency department with a fever and no obvious cause often get blood tests and antibiotics just in case. Researchers are testing whether a rapid finger-prick procalcitonin test, combined with a set of clinical rules, can help doctors identify which children are at low risk of a serious bacterial infection. The trial enrolls children under three years old with fever and no clear source. The goal is to see whether this approach reduces antibiotic prescriptions without missing dangerous infections.

What this could mean

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

Active substance
a rapid finger-prick procalcitonin test combined with a clinical prediction rule
What this could lead to
If it works, doctors could use a quick finger-prick test to spot which young children with fever need antibiotics and which do not, sparing some children painful blood draws and unnecessary medicine.
What could go wrong
The test may not reliably separate serious infections from mild ones in very young children, and a missed infection would be dangerous. The approach also depends on emergency staff following the algorithm consistently.

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

4,928 people

The number who actually took part.

Started

Nov 2018

Finished

Dec 2021

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

6 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 aged 6 days to \<36 months old presenting to an ED at their initial visit with an acute illness for a maximum of 8 days and diagnosed with a FWS defined as body temperature (measured at home or the ED) \> 38°C and a physical examination by a physician without source * Oral non-opposition will be requested from one of the parents or caregivers of the patient. * No current antibiotic treatment or within the 48 hours before the ED presentation. * Parental affiliation with an appropriate health insurance system * Parents speaking French Exclusion Criteria: * A clear source of fever identified after a careful inspection of medical history and a physical examination * No fever on consultation or previously subjectively assessed by parents without use of a thermometer * Refusal of the parents to participate * Child ≥ 36 months or \< 6 days old (ie, early-onset neonatal infection) * Ongoing ABT treatment or within the 48 hours before ED presentation * Children with FWS who revisited the ED after their initial visit * Participation with another interventional study involving human subjects or being in the exclusion period at the end of a previous study involving human subjects

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Conditions

The condition(s) this trial relates to.

meningitis urinary tract infection

As listed by the trial registrant

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

Fever without source

Contacts and locations

Locations

  • AP-HP Antoine Béclère

    Clamart, France

  • AP-HP Necker-Enfants Malades

    Paris, France

  • AP-HP Robert Debré

    Paris, France

  • CHD Vendée

    La Roche-sur-Yon, France

  • CHU

    Rouen, France

  • Centre Hospitalier Intercommunal

    Créteil, France

  • Chu Saint Etienne

    Saint-Etienne, France

  • Hopital Louis Mourier

    Colombes, France

  • Hopital des Enfants

    Geneva, Switzerland

  • Hospices civils de Lyon

    Lyon, France

  • Regional University Hospital

    Lille, France

  • Regional University Hospital

    Nancy, France

  • Regional University Hospital

    Rennes, France

  • Saint Antoine Saint Vincent Hospital

    Lille, France

  • Saint Brieuc Hospital

    Saint-Brieuc, France

  • Southern Bretagne Hospital

    Lorient, France

  • University Hospital

    Angers, France

  • University Hospital

    Bordeaux, France

  • University Hospital

    Brest, France

  • University Hospital

    Caen, France

  • University Hospital

    Clermont-Ferrand, France

  • University Hospital

    Grenoble, France

  • University Hospital

    Montpellier, France

  • University Hospital

    Nice, France

  • University Hospital

    Strasbourg, France

  • University Hospital

    Toulouse, France