Therapeutic Follow-up of Antibiotics in Pediatric Intensive Care

Not yet recruiting

• Conditions: Intensive Care Units, Pediatric

• Registration Number: NCT05354635
• Lead Sponsor: Centre Hospitalier Universitaire de la Réunion

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-26
• Study First Submitted QC: 2022-04-26
• Last Update Submitted: 2022-04-26
• Study First Posted: 2022-04-29
• Last Update Posted: 2022-04-29
• Study Start: 2022-06
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	2 months	Underdosing is defined as a measurement of plasma concentration below the optimal therapeutic concentration (OTC)

Trial Locations

Locations (1)

CHU de la Réunion; 🇷🇪 Saint-Denis, Réunion