Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:51 AM
Study NCT ID:
NCT07327502
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-08
First Post:
2025-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibiotics Distribution Study in Peripheral Compartments: Contribution of Microdialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008480', 'term': 'Mediastinitis'}], 'ancestors': [{'id': 'D008477', 'term': 'Mediastinal Diseases'}, {'id': 'D013896', 'term': 'Thoracic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017551', 'term': 'Microdialysis'}], 'ancestors': [{'id': 'D003956', 'term': 'Dialysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-02', 'studyFirstSubmitDate': '2025-12-08', 'studyFirstSubmitQcDate': '2026-01-02', 'lastUpdatePostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total clearance', 'timeFrame': '36 hours', 'description': 'Pharmacokinetics of cefazolin total clearance in children after cardiac surgery and inter-individual variability.'}, {'measure': 'Distribution volume', 'timeFrame': '36 hours', 'description': 'Pharmacokinetics of cefazolin distribution volume in children after cardiac surgery and inter-individual variability.'}, {'measure': 'Inter-compartmental clearance', 'timeFrame': '36 hours', 'description': 'Pharmacokinetics of cefazolin inter-compartmental clearance in children after cardiac surgery and inter-individual variability.'}], 'secondaryOutcomes': [{'measure': 'Monte Carlo simulations and dosing optimization', 'timeFrame': '36 hours', 'description': '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.'}, {'measure': 'post-operative mediastinitis occurrence', 'timeFrame': 'Month 1', 'description': 'Assess the relationship between tissue exposure and clinical outcome: occurrence of post-operative mediastinitis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cefazolin', 'Cardiac surgery', 'Mediastinitis', 'Microdialysis'], 'conditions': ['Children in Cardiac Intensive Care Requiring Surgery for Congenital Heart Disease']}, 'referencesModule': {'references': [{'pmid': '27317707', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25527166', 'type': 'BACKGROUND', 'citation': 'Andreas 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nDuring 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child aged over 6 months and under 6 years\n* Hospitalized in pediatric cardiac intensive care after cardiac surgery for congenital heart disease.\n* Selected congenital heart diseases: ventricular septal defect auricular septal defect, pulmonary stenosis, tetralogy of Fallot\n* Surgery with median sternotomy and intraoperative cardiopulmonary bypass\n* Intraoperative antibiotic prophylaxis with cefazolin\n* Patient affiliated with a social security plan or eligible\n* whose two parents or legal guardians have accepted and signed the study consent\n\nExclusion Criteria:\n\n* Emergency cardiac surgery\n* Patient already enrolled in the study\n* Patient who has previously undergone cardiac surgery\n* Patient with haemostasis disorders or immune deficiency\n* Patient with bacterial colonization indicating antibiotic prophylaxis other than cefazolin\n* Participation in another interventional research study'}, 'identificationModule': {'nctId': 'NCT07327502', 'acronym': 'Antimidis', 'briefTitle': 'Antibiotics Distribution Study in Peripheral Compartments: Contribution of Microdialysis', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Cefazolin Distribution in Mediastinum After Heart Surgery in Children Using a Microdialysis Probe.', 'orgStudyIdInfo': {'id': 'APHP241591'}, 'secondaryIdInfos': [{'id': '2025-521988-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cefazolin measurements', 'description': 'Microdialysis probe placement and blood drawings to measure cefazolin concentration in mediastinum tissue and in plasma.', 'interventionNames': ['Procedure: Microdialysis probe placement', 'Procedure: Microdialysis and Plasma samples']}], 'interventions': [{'name': 'Microdialysis probe placement', 'type': 'PROCEDURE', 'description': 'Microdialysis probe is placed at the end of cardiac surgery in mediastinum and used during 36 hours for tissue samples until withdrawal.', 'armGroupLabels': ['Cefazolin measurements']}, {'name': 'Microdialysis and Plasma samples', 'type': 'PROCEDURE', 'description': '26 Cefazolin Free tissue concentrations 6 total plasma concentrations', 'armGroupLabels': ['Cefazolin measurements']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'contacts': [{'name': 'Margaux Pontailler, MD', 'role': 'CONTACT', 'email': 'margaux.pontailler@aphp.fr', 'phone': '01 71 39 65 72', 'phoneExt': '+33'}, {'name': 'Gael PLASTOW', 'role': 'CONTACT', 'email': 'gael.plastow@aphp.fr', 'phone': '01 44 38 18 57', 'phoneExt': '+33'}], 'facility': 'Hôpital Necker Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Noemie De Cacqueray, MD', 'role': 'CONTACT', 'email': 'noemie.decacquerayvalmenier@aphp.fr', 'phone': '07 50 91 72 02', 'phoneExt': '+33'}, {'name': 'Gael Plastow', 'role': 'CONTACT', 'email': 'gael.plastow@aphp.fr', 'phone': '01 44 38 18 57', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Margaux Pontailler, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}