CEFAZOLIN for Infection prophylaxis

Inclusion criteria

• {"criterion_text":"- Children between 3 months and 2 years old"}
• {"criterion_text":"- Hospitalized in paediatric cardiac surgical intensive care following cardiac surgery for congenital heart disease"}
• {"criterion_text":"- Selected congenital heart diseases: ventricular septal defect (VSD), atrial septal defect (ASD), pulmonary stenosis, tetralogy of Fallot"}
• {"criterion_text":"- Surgery with sternotomy and intraoperative cardiopulmonary bypass"}
• {"criterion_text":"- Intraoperative antibiotic prophylaxis with cefazoline"}
• {"criterion_text":"- Beneficiary of a social security coverage (affiliated or entitled)"}
• {"criterion_text":"- Whose legal guardians have accepted and signed the study consent form"}
• {"criterion_text":"- Patient whose legal representatives are able to understand the information provided"}

Exclusion criteria

• {"criterion_text":"- Emergency cardiac surgery"}
• {"criterion_text":"- Patient whose relative is the investigator that enrolled them in the study"}
• {"criterion_text":"- Patient with a history of cardiac or thoracic surgery"}
• {"criterion_text":"- Patient with haemostasis disorders or immunodeficiency"}
• {"criterion_text":"- Patient with bacterial colonization indicating antibiotic prophylaxis other than cefazolin"}
• {"criterion_text":"- Hypersensitivity to the active substance, to cephalosporin or penicillin antibiotics"}
• {"criterion_text":"- Participation in another interventional study"}
• {"criterion_text":"- Patient already enrolled in the trial"}
• {"criterion_text":"- Contraindication to microdialysis or surgery"}
• {"criterion_text":"- Administration of another treatment that may interact with cefazolin, or treatment with cefazolin within the previous 7 days"}

Primary endpoints

• {"endpoint_text":"- Population pharmacokinetic parameters and inter-individual variability: distribution volume, total clearance, intercompartmental clearance (plasma to mediastinum)","definition_or_measurement_approach":"Estimated population pharmacokinetic parameters (distribution volume, total clearance, intercompartmental clearance) and inter-individual variability derived from collected pharmacokinetic data."}

Secondary endpoints

• {"endpoint_text":"- Monte Carlo simulations performed using the model with SimulX (version 2024R1) and R (version 4.4.2) software","definition_or_measurement_approach":"Monte Carlo simulations executed using the constructed PK model with SimulX 2024R1 and R 4.4.2 as specified."}
• {"endpoint_text":"- Data collected during the month following probe removal: Clinical progression: survival or death, post-operative mediastinitis, other bacterial infections, MIC of the bacteria if measured; Antibiotics received; Inflammation markers and progression: CRP.","definition_or_measurement_approach":"Clinical and laboratory data collected for one month after probe removal including survival, occurrence of post-operative mediastinitis and other infections, MIC if available, antibiotics administered, and CRP measurements."}

France

Earliest CTIS Part Ii Submission Date

15-12-2025

Latest Decision Or Authorization Date

07-04-2026

Processing Time Days

113

Number Of Sites

2

Number Of Participants

10

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France