RecruitingNot ApplicableNCT05350813

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

Impact of Procalcitonin-guided Algorithm on Early Discontinuation of Antibiotic Therapy in Pediatric Intensive Care Units : a Multicenter Randomized Controlled Trial

Sponsor

University Hospital, Toulouse

Enrollment

296 participants

Start Date

May 2, 2023

Study Type

INTERVENTIONAL

Conditions

Bacterial Infections

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

Min Age: 3 DaysMax Age: 17 Years

Inclusion Criteria4

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 Criteria10

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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Interventions

PROCEDUREMeasurement of the PCT plasma levels

antibiotic treatment duration will be based on PCT plasma levels

PROCEDUREUsual 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.