Children in Cardiac Intensive Care Requiring Surgery for Congenital Heart DiseaseAntimidisNCT07327502
Antibiotics Distribution Study in Peripheral Compartments: Contribution of Microdialysis
A study testing Microdialysis probe placement and Microdialysis and Plasma samples in people with Children in Cardiac Intensive Care Requiring Surgery for Congenital Heart Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Children in Cardiac Intensive Care Requiring Surgery for Congenital Heart Disease
- What is being tested?
- Microdialysis probe placement and Microdialysis and Plasma samples
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Necker Enfants Malades
Paris, Île-de-France Region, 75015
Margaux Pontailler, MD, 01 71 39 65 72 ext. +33, margaux.pontailler@aphp.fr
Gael PLASTOW, 01 44 38 18 57 ext. +33, gael.plastow@aphp.fr
About this study
Official title: Cefazolin Distribution in Mediastinum After Heart Surgery in Children Using a Microdialysis Probe.
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.
Read the detailed description
Children with congenital heart disease are very fragile during the postoperative period and at risk of life-threatening mediastinitis due to various factors: post-extracorporeal circulation inflammation, frequent organ failure, possible delayed thorax closure. These patients are at risk of unpredictable pharmacokinetics alteration and inter-individual variability of the drug tissue: significant fluid intake, drug metabolism and elimination functions alteration, extracorporeal circulation. The effective prevention of postoperative mediastinitis in this population is therefore a major issue and challenge. Studying the distribution of cefazolin in the mediastinum and identifying the factors of inter-individual variability would improve the prevention of this pathology by optimizing the dosing.
During cardiac surgery, a microdialysis probe is placed by the surgeon in the mediastinum. The outgoing fluid will be collected every 30 minutes to every 2 hours, for approximately 28 hours. Six plasma samples will be drawn over these 28 hours to measure plasma concentrations. The probe's recovery will then be calculated and the probe will be removed up to 36 hours after insertion.
- Being tested
- Microdialysis probe placement, Microdialysis and Plasma samples
- Keywords
- Cefazolin, Cardiac surgery, Mediastinitis, Microdialysis
- Medical subject headings
- Mediastinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microdialysis probe placementProcedure or surgery
Microdialysis probe is placed at the end of cardiac surgery in mediastinum and used during 36 hours for tissue samples until withdrawal.
Microdialysis and Plasma samplesProcedure or surgery
26 Cefazolin Free tissue concentrations 6 total plasma concentrations
| Study group | Role | What they receive |
|---|---|---|
| Cefazolin measurements | Experimental | Microdialysis probe placement and blood drawings to measure cefazolin concentration in mediastinum tissue and in plasma. Receives: Procedure: Microdialysis probe placement; Procedure: Microdialysis and Plasma samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total clearance
Pharmacokinetics of cefazolin total clearance in children after cardiac surgery and inter-individual variability.
Measured: 36 hours
Distribution volume
Pharmacokinetics of cefazolin distribution volume in children after cardiac surgery and inter-individual variability.
Measured: 36 hours
Inter-compartmental clearance
Pharmacokinetics of cefazolin inter-compartmental clearance in children after cardiac surgery and inter-individual variability.
Measured: 36 hours
Secondary outcomes (2)
Monte Carlo simulations and dosing optimization
Monte Carlo simulations performed using the model with SimulX (version 2024R1) and R (version 4.4.2) softwares. Probability of attainment of PK/PD target (100 % ƒT > 4xCMI) with simulated dosing regimens No patient data is required for this step.
Measured: 36 hours
post-operative mediastinitis occurrence
Assess the relationship between tissue exposure and clinical outcome: occurrence of post-operative mediastinitis
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Children in Cardiac Intensive Care Requiring Surgery for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Margaux Pontailler, MD, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327502
- Sponsor's protocol ID
- APHP241591
- Other IDs
- 2025-521988-13, 2025
- Acronym
- Antimidis
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Himebauch AS, Sankar WN, Flynn JM, Sisko MT, Moorthy GS, Gerber JS, Zuppa AF, Fox E, Dormans JP, Kilbaugh TJ. Skeletal muscle and plasma concentrations of cefazolin during complex paediatric spinal surgery. Br J Anaesth. 2016 Jul;117(1):87-94. doi: 10.1093/bja/aew032.
PubMed 27317707Andreas M, Zeitlinger M, Wisser W, Jaeger W, Maier-Salamon A, Thalhammer F, Kocher A, Hiesmayr JM, Laufer G, Hutschala D. Cefazolin and linezolid penetration into sternal cancellous bone during coronary artery bypass grafting. Eur J Cardiothorac Surg. 2015 Nov;48(5):758-64. doi: 10.1093/ejcts/ezu491. Epub 2014 Dec 18.
PubMed 25527166
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cefazolin Distribution in Mediastinum After Heart Surgery in Children Using a Microdialysis Probe.
- ClinicalTrials.gov ID
- NCT07327502
- Acronym / sponsor ID
- Antimidis / APHP241591
- Keywords
- Cefazolin, Cardiac surgery, Mediastinitis, Microdialysis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Jan 2026 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Children with congenital heart disease are very fragile during the postoperative period and at risk of life-threatening mediastinitis due to various factors: post-extracorporeal circulation inflammation, frequent organ failure, possible delayed thorax closure. These patients are at risk of unpredictable pharmacokinetics alteration and inter-individual variability of the drug tissue: significant fluid intake, drug metabolism and elimination functions alteration, extracorporeal circulation. The effective prevention of postoperative mediastinitis in this population is therefore a major issue and challenge. Studying the distribution of cefazolin in the mediastinum and identifying the factors of inter-individual variability would improve the prevention of this pathology by optimizing the dosing.
During cardiac surgery, a microdialysis probe is placed by the surgeon in the mediastinum. The outgoing fluid will be collected every 30 minutes to every 2 hours, for approximately 28 hours. Six plasma samples will be drawn over these 28 hours to measure plasma concentrations. The probe's recovery will then be calculated and the probe will be removed up to 36 hours after insertion.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cefazolin measurements | Experimental | Procedure: Microdialysis probe placement, Procedure: Microdialysis and Plasma samplesMicrodialysis probe placement and blood drawings to measure cefazolin concentration in mediastinum tissue and in plasma. |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microdialysis probe placementMicrodialysis probe is placed at the end of cardiac surgery in mediastinum and used during 36 hours for tissue samples until withdrawal. | Procedure or surgery | Cefazolin measurements |
| Microdialysis and Plasma samples26 Cefazolin Free tissue concentrations 6 total plasma concentrations | Procedure or surgery | Cefazolin measurements |
Primary outcome
Total clearance
Time frame: 36 hours
Pharmacokinetics of cefazolin total clearance in children after cardiac surgery and inter-individual variability.
Distribution volume
Time frame: 36 hours
Pharmacokinetics of cefazolin distribution volume in children after cardiac surgery and inter-individual variability.
Inter-compartmental clearance
Time frame: 36 hours
Pharmacokinetics of cefazolin inter-compartmental clearance in children after cardiac surgery and inter-individual variability.
2 secondary outcomes
Monte Carlo simulations and dosing optimization
Time frame: 36 hours
post-operative mediastinitis occurrence
Time frame: Month 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Background: PubMed 27317707Himebauch AS, Sankar WN, Flynn JM, Sisko MT, Moorthy GS, Gerber JS, Zuppa AF, Fox E, Dormans JP, Kilbaugh TJ. Skeletal muscle and plasma concentrations of cefazolin during complex paediatric spinal surgery. Br J Anaesth. 2016 Jul;117(1):87-94. doi: 10.1093/bja/aew032.
- Background: PubMed 25527166Andreas M, Zeitlinger M, Wisser W, Jaeger W, Maier-Salamon A, Thalhammer F, Kocher A, Hiesmayr JM, Laufer G, Hutschala D. Cefazolin and linezolid penetration into sternal cancellous bone during coronary artery bypass grafting. Eur J Cardiothorac Surg. 2015 Nov;48(5):758-64. doi: 10.1093/ejcts/ezu491. Epub 2014 Dec 18.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Margaux Pontailler, MD study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microdialysis probe placement and Microdialysis and Plasma samples in people with Children in Cardiac Intensive Care Requiring Surgery for Congenital Heart Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noemie De Cacqueray, MD (07 50 91 72 02 ext. +33, noemie.decacquerayvalmenier@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total clearance (time frame: 36 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07327502, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.