Using procalcitonin levels to guide antibiotic treatment in critically ill children
Impact of Procalcitonin-guided Algorithm on Early Discontinuation of Antibiotic Therapy in Pediatric Intensive Care Units : a Multicenter Randomized Controlled Trial
This study is testing if using procalcitonin levels can help doctors safely shorten antibiotic treatment for critically ill children with bacterial infections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 296 (estimated) |
| Ages | 3 Days to 17 Years |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Amiens and 6 other locations) |
| Trial ID | NCT05350813 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include neonates, infants, and children hospitalized in Pediatric and Neonatal ICUs who are receiving intravenous antibiotics for less than 24 hours for bacterial infections.
Not a fit: Patients who are immunocompromised, have cystic fibrosis, or are newborns less than 72 hours old will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to shorter antibiotic courses, reducing the risk of antibiotic resistance and associated adverse effects in critically ill children.
How similar studies have performed: While similar studies in adults have shown efficacy, data in critically ill children is limited, making this approach novel in this specific population.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Amiens and 6 other locations
- CHU Amiens Picardie — Amiens, France (Active_not_recruiting)
- CHU de Bordeaux — Bordeaux, France (Active_not_recruiting)
- CHU de Clermont Ferrand — Clermont-Ferrand, France (Recruiting)
- CHU de NANTES — Nantes, France (Recruiting)
- Aphp — Paris, France (Active_not_recruiting)
- CHU La Réunion — Saint-Denis, France (Recruiting)
- University Hospital of Toulouse — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Romain AMADIEU, MD — University Hospital of Toulouse
- Study coordinator: Romain AMADIEU, MD
- Email: amadieu.r@chu-toulouse.fr
- Phone: 053-455-7495
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.