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RECRUITING
NCT05350813
NA

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

Sponsor: University Hospital, Toulouse

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

3 Days - 17 Years

Study Type

INTERVENTIONAL

Enrollment

296

Start Date

2023-05-02

Completion Date

2027-02-02

Last Updated

2024-09-25

Healthy Volunteers

No

Interventions

PROCEDURE

Measurement of the PCT plasma levels

antibiotic treatment duration will be based on PCT plasma levels

PROCEDURE

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.

Locations (7)

CHU Amiens Picardie

Amiens, France

CHU de Bordeaux

Bordeaux, France

CHU de Clermont Ferrand

Clermont-Ferrand, France

CHU de NANTES

Nantes, France

APHP

Paris, France

CHU La Réunion

Saint-Denis, France

University Hospital of Toulouse

Toulouse, France