Therapeutic Follow-up of Antibiotics in Pediatric Intensive Care

Intensive Care Units, Pediatric Clinical Trial

— STAR-P  

Official title:

Therapeutic Follow-up of Antibiotics in Pediatric Intensive Care

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05354635
• Other study ID #: 2022/CHU/05
• Status: Not yet recruiting
• Start date: June 2022
• Est. completion date: June 2025

Study information

• Verified date: April 2022
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: Lise PEIPOCH, MD
• Phone: +262 262 90 63 90
• Email: lise.peipoch[@]chu-reunion.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 280
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Intensive Care Units, Pediatric

Intervention

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

Locations

Country	Name	City	State
Réunion	CHU de la Réunion	Saint-Denis

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

Réunion, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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