Antibiotics Distribution Study in Peripheral Compartments: Contribution of Microdialysis (NCT07327502) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Antibiotics Distribution Study in Peripheral Compartments: Contribution of Microdialysis
France10 participantsStarted 2026-01
Plain-language 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.
Who can participate
Age range
6 Months – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Child aged over 6 months and under 6 years
* Hospitalized in pediatric cardiac intensive care after cardiac surgery for congenital heart disease.
* Selected congenital heart diseases: ventricular septal defect auricular septal defect, pulmonary stenosis, tetralogy of Fallot
* Surgery with median sternotomy and intraoperative cardiopulmonary bypass
* Intraoperative antibiotic prophylaxis with cefazolin
* Patient affiliated with a social security plan or eligible
* whose two parents or legal guardians have accepted and signed the study consent
Exclusion Criteria:
* Emergency cardiac surgery
* Patient already enrolled in the study
* Patient who has previously undergone cardiac surgery
* Patient with haemostasis disorders or immune deficiency
* Patient with bacterial colonization indicating antibiotic prophylaxis other than cefazolin
* Participation in another interventional research study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.