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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-17
SponsorUniversity Hospital, Toulouse

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Newborns <72 hours old.

Neonates <37 weeks postmenstrual age.

Age ≥18 years.

Pregnant or breastfeeding women.

Trial design

Treatments tested in this trial

  • Measurement of the PCT plasma levels
  • Usual practice based on guidelines

Treatment groups

296 Participants
are divided into 2 treatment groups

Sponsors and collaborators