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Could a simple blood test curb antibiotic overuse in sick kids?

NCT ID NCT05350813

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial tests whether using a blood marker called procalcitonin (PCT) to guide antibiotic decisions can safely shorten treatment duration in children with bacterial infections in intensive care. About 296 children will be randomly assigned to either PCT-guided care or standard practice, and their total antibiotic use will be compared over 28 days. The goal is to see if this approach reduces unnecessary antibiotic exposure without compromising recovery.

What this could mean

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

Active substance
A procalcitonin (PCT)-guided algorithm to determine when to stop antibiotics, compared with standard care based on guidelines.
What this could lead to
If effective, this approach could reduce unnecessary antibiotic exposure in hospitalized children, lowering side effects and the risk of antibiotic resistance.
What could go wrong
The trial is relatively small and open-label, which may introduce bias. The algorithm may not be suitable for all infections, and there is a risk of undertreatment if it guides stopping antibiotics too early.

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

About 296 people

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

Started

May 2023

Expected to finish

Feb 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.

Ages

3 days to 17 years

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: * Neonates, infants and children hospitalized in Pediatric and Neonatal ICU and receiving intravenous antibiotics for less than 24 hours for an episode of suspected or proven community-acquired or nosocomial bacterial infection. * Written informed consent signed by both parents or legal guardians. * Affiliated to a social security scheme. * Parents French-speaking. Exclusion Criteria: * Newborns \<72 hours old. * Neonates \<37 weeks postmenstrual age. * Age ≥18 years. * Pregnant or breastfeeding women. * Patients with cystic fibrosis. * Immunocompromised patients including patients with hereditary immunodeficiency, agranulocytosis (neutrophils count \<500/mm3), HIV infection with CD4 count \<200/mm3, sickle cell disease, those who have undergone splenectomy, those who have a history of solid organ or hematopoietic stem cell transplant, those with hemopathy or solid organ tumor treated with chemotherapy, and those on immunosuppressive drugs including systemic corticosteroids taken daily for at least 15 days prior to Day 0. * Inflammatory situations increasing PCT plasma concentrations in the absence of infection: burns, extracorporeal membrane oxygenation (ECMO), first 48 hours following an open-heart cardiac surgery with cardiopulmonary bypass. * Infections requiring prolonged antibiotic therapy: infected thrombophlebitis, infective endocarditis, mediastinitis, abscess or empyema (e.g. peritonsillar abscess, retropharyngeal abscess, adenophlegmon, retroauricular abscess, retroorbital abscess, pulmonary abscess, pleural empyema, liver abscess, splenic abscess, brain abscess, subdural empyema, extradural empyema, epidural abscess, intramuscular abscess), necrotizing dermohypodermitis or necrotizing fasciitis, osteomyelitis, osteitis, arthritis, spondylodiscitis, prostatitis, tuberculosis, meningitis except those caused by Haemophilus and Meningococcus, infection on a device excluding intravascular catheter, endotracheal tube, tracheostomy, and urinary catheter. * Antibiotic for prophylaxis. * Children previously included in an interventional study in progress.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    4 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

  • APHP

    ACTIVE_NOT_RECRUITING

    Paris, France

  • CHU Amiens Picardie

    ACTIVE_NOT_RECRUITING

    Amiens, France

  • CHU La Réunion

    RECRUITING

    Saint-Denis, France

  • CHU de Bordeaux

    ACTIVE_NOT_RECRUITING

    Bordeaux, France

  • CHU de Clermont Ferrand

    RECRUITING

    Clermont-Ferrand, France

  • CHU de NANTES

    RECRUITING

    Nantes, France

  • University Hospital of Lille

    TERMINATED

    Lille, France

  • University Hospital of Toulouse

    RECRUITING

    Toulouse, 31100, France

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