Could a simple blood test curb antibiotic overuse in sick kids?
NCT ID NCT05350813
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
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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
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About 296 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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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
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3 days to 17 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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APHP
ACTIVE_NOT_RECRUITINGParis, France
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CHU Amiens Picardie
ACTIVE_NOT_RECRUITINGAmiens, France
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CHU La Réunion
RECRUITINGSaint-Denis, France
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CHU de Bordeaux
ACTIVE_NOT_RECRUITINGBordeaux, France
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CHU de Clermont Ferrand
RECRUITINGClermont-Ferrand, France
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CHU de NANTES
RECRUITINGNantes, France
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University Hospital of Lille
TERMINATEDLille, France
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University Hospital of Toulouse
RECRUITINGToulouse, 31100, France
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