Status:
RECRUITING
Impact of Procalcitonin-guided Algorithm on Early Discontinuation of Antibiotic Therapy
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Bacterial Infections
Eligibility:
All Genders
3-17 years
Phase:
NA
Brief Summary
In this randomized controlled open-label trial, conducted in 7 French Pediatric and Neonatal Intensive Care Units (ICUs), investigator team hypothesize that the use of a procalcitonin (PCT)-guided alg...
Detailed Description
Infections are widespread in Pediatric and Neonatal ICU, and antibiotic treatments widely used. Long courses of antibiotic treatment increase the duration of hospitalization and are associated with ch...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 2 2027
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT05350813
Start Date
May 2 2023
End Date
February 2 2027
Last Update
September 25 2024
Active Locations (7)
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1
CHU Amiens Picardie
Amiens, France
2
CHU de Bordeaux
Bordeaux, France
3
CHU de Clermont Ferrand
Clermont-Ferrand, France
4
CHU de NANTES
Nantes, France