Therapeutic Follow-up of Antibiotics in Pediatric Intensive Care

NCT ID: NCT05354635

Last Updated: 2022-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

280 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-30

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intensive Care Units, Pediatric

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Antibiotics Dosing

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU de la Réunion

Saint-Denis, , Reunion

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Reunion

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lise PEIPOCH, MD

Role: CONTACT

Phone: +262 262 90 63 90

Email: [email protected]

Laetitia BERLY, PhD

Role: CONTACT

Phone: +262 262 90 62 86

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lise PEIPOCH, MD

Role: primary

Théa VENET, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022/CHU/05

Identifier Type: -

Identifier Source: org_study_id