Impact of Procalcitonin-guided Algorithm on Early Discontinuation of Antibiotic Therapy

NCT05350813 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Toulouse

Phase

Not applicable

Started

2023-05-02

Last updated

2026-08-11

Condition(s) studied

Bacterial Infections

Investigational drug(s) / intervention(s)

Measurement of the PCT plasma levelsUsual practice based on guidelines

Measurement of the PCT plasma levels: antibiotic treatment duration will be based on PCT plasma levels

Usual practice based on guidelines: antibiotic therapy duration will be determined by the type of infection, microbiological results and clinical, biological and/or radiological evolution, according to the usual practice based on guidelines.

Study 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 algorithm to discontinue antibiotic treatment will decrease antibiotic duration in critically ill children treated for a suspected or proven bacterial infection. Two hundred and ninety-six eligible patients will be randomly assigned in two groups: either PCT-guided or standard-of-care antibiotic discontinuation, and monitored over 28 days, until the end of their hospitalization, or up to the end of antibiotic treatment for bacterial infection recurrence occurring up to 28 days after the day of randomization.

Eligibility

Sex

ALL

Min age

3 Days

Max age

17 Years

Healthy volunteers

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.

Primary outcome measure(s)

Total duration of antibiotic therapy (in days) for a suspected or proven bacterial infection, including the first episode and recurrences occurring within 28 days following the day of randomization — month 3 (maximum follow-up period of 3 months)
Duration of antibiotic therapy (in days) including the length of treatment for recurrences occurring within 28 days following the day of randomization. The duration of antibiotic therapy for the first episode of suspected or proven bacterial infection is the time interval, expressed in days, between the starting time of intravenous antibiotics and the stopping time of the antibiotic therapy (intravenous, intramuscular or oral). The duration of antibiotic therapy for a recurrence of bacterial infection is the time interval, expressed in days, between the starting time of a new antimicrobial therapy (intravenous, intramuscular or oral) covering the initial causative bacteria within 28 days following the day of randomization, and the stopping time of this antibiotic therapy (even if ending after 28 days following the day of randomization).

Trial sites (8)

Facility	City	Region	Status
CHU Amiens Picardie	Amiens	France	Active Not Recruiting
CHU de Bordeaux	Bordeaux	France	Active Not Recruiting
CHU de Clermont Ferrand	Clermont-Ferrand	France	Recruiting
University Hospital of Lille	Lille	France	Terminated
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05350813 on ClinicalTrials.gov ↗ ← All trials in France