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Therapeutic Follow-up of Antibiotics in Pediatric Intensive Care

Therapeutic Follow-up of Antibiotics in Pediatric Intensive Care

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05354635
Acronym
STAR-P
Enrollment
280
Registered
2022-04-29
Start date
2022-06-30
Completion date
2025-06-30
Last updated
2022-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Units, Pediatric

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.

Interventions

OTHERAntibiotics Dosing

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

Sponsors

Centre Hospitalier Universitaire de la Réunion
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 monthsUnderdosing is defined as a measurement of plasma concentration below the optimal therapeutic concentration (OTC)

Countries

Reunion

Contacts

Primary ContactLise PEIPOCH, MD
lise.peipoch@chu-reunion.fr+262 262 90 63 90
Backup ContactLaetitia BERLY, PhD
laetitia.berly@chu-reunion.fr+262 262 90 62 86

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026