Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Not authorised
Participants planned
10
Countries
1
Sites
2
Infection prophylaxis
To describe the cefazolin mediastinal distribution in children’s mediastinum after undergoing cardiac surgery
Key facts
- Sponsor
- Assistance Publique Hopitaux De Paris
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Decision date (initial)
- 2026-04-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-521988-13-00
- ClinicalTrials.gov
- NCT07327502
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Pharmacokinetic
To describe the cefazolin mediastinal distribution in children’s mediastinum after undergoing cardiac surgery
Secondary objectives 2
- To perform Monte Carlo simulations based on the model constructed to suggest ideal, optimised and individualised dosages of prophylactic cefazolin during cardiac surgery in children
- To establish a relationship between tissue exposure and clinical outcome: occurrence of post-operative mediastinitis
Conditions and MedDRA coding
Infection prophylaxis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10042613 | Surgical and medical procedures | 25 |
| 20.0 | PT | 10049924 | Infection prophylaxis | 100000004865 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Children between 3 months and 2 years old
- Hospitalized in paediatric cardiac surgical intensive care following cardiac surgery for congenital heart disease
- Selected congenital heart diseases: ventricular septal defect (VSD), atrial septal defect (ASD), pulmonary stenosis, tetralogy of Fallot
- Surgery with sternotomy and intraoperative cardiopulmonary bypass
- Intraoperative antibiotic prophylaxis with cefazoline
- Beneficiary of a social security coverage (affiliated or entitled)
- Whose legal guardians have accepted and signed the study consent form
- Patient whose legal representatives are able to understand the information provided
Exclusion criteria 10
- Emergency cardiac surgery
- Patient with a history of cardiac or thoracic surgery
- Patient with haemostasis disorders or immunodeficiency
- Patient with bacterial colonization indicating antibiotic prophylaxis other than cefazolin
- Hypersensitivity to the active substance, to cephalosporin or penicillin antibiotics
- Participation in another interventional study
- Patient already enrolled in the trial
- Contraindication to microdialysis or surgery
- Administration of another treatment that may interact with cefazolin, or treatment with cefazolin within the previous 7 days
- Patient whose relative is the investigator that enrolled them in the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Population pharmacokinetic parameters and inter-individual variability: distribution volume, total clearance, intercompartmental clearance (plasma to mediastinum)
Secondary endpoints 2
- Monte Carlo simulations performed using the model with SimulX (version 2024R1) and R (version 4.4.2) software
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB07379MIG · Substance
- Active substance
- Cefazolin
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION OR INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 75 mg/kg milligram(s)/kilogram
- Max total dose
- 75 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Assistance Publique Hopitaux De Paris
- Sponsor organisation
- Assistance Publique Hopitaux De Paris
- Address
- Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux
- City
- Paris Cedex 10
- Postcode
- 75475
- Country
- France
Scientific contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Margaux PONTAILLER
Public contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Margaux PONTAILLER
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Not authorised | 10 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-521988-13-00 | 1-4 |
| Recruitment arrangements (for publication) | K2_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Autorite Parentale | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_CEFAZOLINE_2403225 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EN 2025-521988-13-00 | 1-5 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis FR 2025-521988-13-00 | 1-5 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-03 | France | Acceptable with conditions 2026-03-30
|
2026-04-07 |