Using procalcitonin levels to guide antibiotic treatment in critically ill children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of a procalcitonin (PCT)-guided algorithm for discontinuing antibiotic therapy in critically ill children with suspected or proven bacterial infections. Conducted in seven Pediatric and Neonatal Intensive Care Units in France, the study randomly assigns 296 eligible patients to either the PCT-guided group or the standard-of-care group. The goal is to determine if the PCT-guided approach can safely reduce the duration of antibiotic treatment without increasing the risk of infection recurrence. Participants will be monitored for 28 days or until the end of their hospitalization.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHU de Clermont Ferrand
  Clermont-Ferrand, France Recruiting
• CHU de NANTES
  Nantes, France Recruiting
• CHU La Réunion
  Saint-Denis, France Recruiting
• University Hospital of Toulouse
  Toulouse, France Recruiting
• CHU Amiens Picardie
  Amiens, France Active not recruiting
• CHU de Bordeaux
  Bordeaux, France Active not recruiting

Study contacts

• Principal investigator: Montserrat SIERRA COLOMINA, MD — University Hospital of Toulouse
• Study coordinator: Montserrat SIERRA COLOMINA, MD
• Email: sierracolomina.m@chu-toulouse.fr
• Phone: 05 61 74 51 45

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.