ANTIMIDIS - Cefazolin mediastinal distribution using microdialysis

Overview

Sponsor-declared trial summary

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)

2026-06-05

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

1. 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
2. To establish a relationship between tissue exposure and clinical outcome: occurrence of post-operative mediastinitis

Conditions and MedDRA coding

Infection prophylaxis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

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

Exclusion criteria 10

1. Emergency cardiac surgery
2. Patient with a history of cardiac or thoracic surgery
3. Patient with haemostasis disorders or immunodeficiency
4. Patient with bacterial colonization indicating antibiotic prophylaxis other than cefazolin
5. Hypersensitivity to the active substance, to cephalosporin or penicillin antibiotics
6. Participation in another interventional study
7. Patient already enrolled in the trial
8. Contraindication to microdialysis or surgery
9. Administration of another treatment that may interact with cefazolin, or treatment with cefazolin within the previous 7 days
10. Patient whose relative is the investigator that enrolled them in the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Population pharmacokinetic parameters and inter-individual variability: distribution volume, total clearance, intercompartmental clearance (plasma to mediastinum)

Secondary endpoints 2

1. Monte Carlo simulations performed using the model with SimulX (version 2024R1) and R (version 4.4.2) software
2. 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

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

Investigational sites

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

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.

Application history

1 submissions — initial application plus substantial / non-substantial modifications