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.
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.
Newborns <72 hours old.
Neonates <37 weeks postmenstrual age.
Age ≥18 years.
Pregnant or breastfeeding women.
Parallel
Measurement of the PCT plasma levels
Procedure/Surgeryantibiotic treatment duration will be based on PCT plasma levels
Usual practice based on guidelines
Procedure/Surgeryantibiotic 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.
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
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).
Total duration of broad-spectrum antibiotic therapy in days) for a suspected or proven bacterial infection, including the first episode and recurrences
Duration of broad-spectrum antibiotic therapy (in days) including the length of treatment for recurrences occurring within 28 days following the day of randomization, and also the length of treatment for recurrences occurring within 28 days following the day of randomization. To identify broad-spectrum antibiotics, we used separately two definitions. Based on the historical definition, broad-spectrum antibiotics were all antibiotics except those with a useful activity against only Gram-positive bacteria (penicillin G, oxacillin, vancomycin, teicoplanin, linezolid, macrolides, clindamycin) and those whose main activity is against Gram-positive bacteria (amoxicillin, 1st generation cephalosporin \[cefazolin, cephalexin\], 2nd generation cephalosporin \[cefuroxime, cefaclor, cefamandole\], rifampicin).
Length of Intensive Care Unit stay (in days) from Day 0 (day of randomization)
Length of Intensive Care Unit stay (in days) from Day 0 (day of randomization)
Length of hospital stay from Day 0 (day of randomization)
Length of hospital stay from Day 0 (day of randomization)
Recurrence of bacterial infection within 28 days following the day of randomization
Proportion of children with recurrence of bacterial infection within 28 days following the day of randomization. The recurrence of bacterial infection is defined as the isolation of one or more of the initial causative bacteria from the same or another site at 48 hours or more after cessation of antibiotics, combined with clinical signs or symptoms of infection, or the need to prescribe a new antimicrobial therapy covering this pathogen. All recurrences of bacterial infection occurring up to Day 28, and treated in hospital (same hospital stay as for the first episode, or new hospital stay) or in ambulatory care, will be taken into account.
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