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Antibiotics Distribution Study in Peripheral Compartments: Contribution of Microdialysis

NCT07327502 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-01-08

No results posted yet for this study

Summary

Postoperative mediastinitis is an important cause of postoperative morbidity in children. The main objective of this study is to describe the distribution of cefazolin, using as surgical antibiotic prophylaxis, in the mediastinal compartment in children after cardiac surgery for congenital heart disease. The investigators aims to build a population pharmacokinetic model of cefazolin using plasma and tissue concentrations in order to optimize and individualize cefazolin dosing regimens. Cefazolin tissue pharmacokinetics will use a microdialysis procedure.

Conditions

  • Children in Cardiac Intensive Care Requiring Surgery for Congenital Heart Disease

Interventions

PROCEDURE

Microdialysis and Plasma samples

26 Cefazolin Free tissue concentrations 6 total plasma concentrations

PROCEDURE

Microdialysis probe placement

Microdialysis probe is placed at the end of cardiac surgery in mediastinum and used during 36 hours for tissue samples until withdrawal.

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Margaux Pontailler, MD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-02-28
Completion
2027-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07327502 on ClinicalTrials.gov