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Not yet recruitingNCT05354635STAR-PUpdated Apr 29, 2022

Therapeutic Follow-up of Antibiotics in Pediatric Intensive Care

An observational study in Intensive Care Units, Pediatric, sponsored by Centre Hospitalier Universitaire de la Réunion. Not yet recruiting at 1 site in Réunion. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2022-04-29.

Sponsored by Centre Hospitalier Universitaire de la Réunion · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
280
Ages
Up to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Intensive Care Units, Pediatric
03

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

-Patients on prophylactic antibiotic therapy

04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
280 participants (estimated)
Patient registry
No

Interventions

  • OtherAntibiotics Dosing

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

05

What researchers measure

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)

    Time frame: 2 months

06

Study locations

1 site
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05354635
Lead sponsor
Centre Hospitalier Universitaire de la Réunion
Responsible party
Sponsor
First posted
Apr 29, 2022
Start date
Jun 2022 (estimated)
Primary completion
Jun 2025 (estimated)
Completion
Jun 2025 (estimated)
Last update
Apr 29, 2022

Study contacts

Lise PEIPOCH, MD
Contact
lise.peipoch@chu-reunion.fr
+262 262 90 63 90
Laetitia BERLY, PhD
Contact
laetitia.berly@chu-reunion.fr
+262 262 90 62 86

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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