Therapeutic Follow-up of Antibiotics in Pediatric Intensive Care (STAR-P)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intensive Care Units, Pediatric
• Intervention / Treatment: Other: Antibiotics Dosing

• Study Type: Observational
• Enrollment (Anticipated): 280

Contacts and Locations

• Study Contact: Name: Lise PEIPOCH, MD; Phone Number: +262 262 90 63 90; Email: lise.peipoch@chu-reunion.fr
• Study Contact Backup: Name: Laetitia BERLY, PhD; Phone Number: +262 262 90 62 86; Email: laetitia.berly@chu-reunion.fr

Study Locations

• Réunion
  • Saint-Denis, Réunion, 97400
    • CHU de la Réunion
    • Contact: Lise PEIPOCH, MD; Phone Number: +262 262 90 63 90; Email: lise.peipoch@chu-reunion.fr
    • Contact: Théa VENET, MD; Phone Number: +262 262 90 63 90; Email: thea.venet@chu-reunion.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2022
• Primary Completion (ANTICIPATED): June 1, 2025
• Study Completion (ANTICIPATED): June 1, 2025

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (ACTUAL): April 29, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 2022/CHU/05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No