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Clinical Trials/NCT05354635
NCT05354635
Not yet recruiting
Not Applicable

Therapeutic Follow-up of Antibiotics in Pediatric Intensive Care

Centre Hospitalier Universitaire de la Réunion1 site in 1 country280 target enrollmentJune 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intensive Care Units, Pediatric
Sponsor
Centre Hospitalier Universitaire de la Réunion
Enrollment
280
Locations
1
Primary Endpoint
The occurrence of at least one "underdosing" event of one of the Antibiotics used in a patient included during his or her hospitalization in pediatrics intensive care unit (PICU)
Status
Not yet recruiting
Last Updated
4 years ago

Overview

Brief Summary

Currently, recommendations for antibiotic testing (ATS) in adult intensive care have been published. The 2018 SFAR and the Abdul- Aziz et al expert conference recommend routine testing for β-lactams, aminoglycosides, linezolid, and vancomycin and provide plasma concentration goals. No recommendations have been made for the pediatric intensive care unit (PICU) population. However, several articles report suboptimal plasma concentrations for the most frequently used antibiotics in PICU. The University Hospital of Reunion is the reference center for the western region of the Indian Ocean. This region presents a large mixed population due to the migratory flow, as well as a specific bacterial ecology. This suggests that the data already collected on antibiotic dosage in other European studies may not be fully extrapolated to Reunion Island.

It is in this context that we will study the plasma concentration of antibiotics for all children who received the most commonly used antibiotics (β-lactams, linezolid, vancomycin, and aminoglycosides) during their hospitalization in PICU.

Registry
clinicaltrials.gov
Start Date
June 2022
End Date
June 2025
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de la Réunion
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Any child hospitalized in the pediatric intensive care unit of the CHU Nord de La Réunion,
  • Age is less than 18 years,
  • Having started a curative antibiotic therapy by β-lactam, linezolid, vancomycin or aminosides.
  • For whom a non-opposition has been collected orally from both or one of the child's legal guardians and from the child himself (if applicable),
  • Covered by Social Security.

Exclusion Criteria

  • Patients on prophylactic antibiotic therapy

Outcomes

Primary Outcomes

The occurrence of at least one "underdosing" event of one of the Antibiotics used in a patient included during his or her hospitalization in pediatrics intensive care unit (PICU)

Time Frame: 2 months

Underdosing is defined as a measurement of plasma concentration below the optimal therapeutic concentration (OTC)

Study Sites (1)

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