Therapeutic Follow-up of Antibiotics in Pediatric Intensive Care

NCT05354635 | Unknown

• 1 other identifier: 2022/CHU/05
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Units, Pediatric

Outcome Measures

Primary Outcomes (1)

• 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)

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

  2 months

Interventions

Antibiotics Dosing OTHER

Dosing concerns the main antibiotics used in the unit: b-lactams, linezolid, vancomycin and aminosides

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The aim of the research is to evaluate the adequacy of antibiotic therapy in children admitted to the pediatric intensive care unit at the University Hospital of La Réunion. The study population is intended to be exhaustive and will include all subjects affiliated to the Social Security who meet the eligibility criteria.

You may qualify if:

• 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.

You may not qualify if:

• Patients on prophylactic antibiotic therapy

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (1)

CHU de la Réunion

Saint-Denis, 97400, Reunion

Location

Central Study Contacts

Lise PEIPOCH, MD

CONTACT

+262 262 90 63 90; lise.peipoch@chu-reunion.fr

Laetitia BERLY, PhD

CONTACT

+262 262 90 62 86; laetitia.berly@chu-reunion.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: April 29, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

RE (1)