Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-01-05 @ 1:27 AM
Study NCT ID:
NCT02479503
Status:
COMPLETED
Last Update Posted:
2020-04-14
First Post:
2015-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibiotic Prophylaxis in Adult Heart Transplantation: a French National Survey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019072', 'term': 'Antibiotic Prophylaxis'}], 'ancestors': [{'id': 'D018890', 'term': 'Chemoprevention'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011292', 'term': 'Premedication'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-13', 'studyFirstSubmitDate': '2015-06-12', 'studyFirstSubmitQcDate': '2015-06-19', 'lastUpdatePostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Class of antibiotic used as prophylaxis in adult heart transplantation', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'Class of antibiotic used as prophylaxis in adult heart transplantation in regard to clinical situation', 'timeFrame': 'one year', 'description': 'elective, emergency, redux surgery, ventricular assisting device or extracorporeal live saving'}, {'measure': 'Fungal prophylaxis in adult heart transplantation', 'timeFrame': 'one year'}, {'measure': 'Other prophylactic measures (isolation, specific room, family visits) used in adult heart transplantation', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['antibiotic prophylaxis heart transplantation'], 'conditions': ['Antibiotic Prophylaxis', 'Adult Heart Transplantation']}, 'referencesModule': {'references': [{'pmid': '21418335', 'type': 'BACKGROUND', 'citation': 'Zuckermann A, Barten MJ. Surgical wound complications after heart transplantation. Transpl Int. 2011 Jul;24(7):627-36. doi: 10.1111/j.1432-2277.2011.01247.x. Epub 2011 Mar 21.'}, {'pmid': '11486285', 'type': 'BACKGROUND', 'citation': 'Montoya JG, Giraldo LF, Efron B, Stinson EB, Gamberg P, Hunt S, Giannetti N, Miller J, Remington JS. Infectious complications among 620 consecutive heart transplant patients at Stanford University Medical Center. Clin Infect Dis. 2001 Sep 1;33(5):629-40. doi: 10.1086/322733. Epub 2001 Aug 6.'}, {'pmid': '18482203', 'type': 'BACKGROUND', 'citation': 'Ramos A, Asensio A, Munez E, Torre-Cisneros J, Blanes M, Carratala J, Segovia J, Munoz P, Cisneros JM, Bou G, Aguado JM, Cervera C, Gurgui MM. Incisional surgical infection in heart transplantation. Transpl Infect Dis. 2008 Jul;10(4):298-302. doi: 10.1111/j.1399-3062.2008.00316.x. Epub 2008 May 15.'}]}, 'descriptionModule': {'briefSummary': 'The study focuses on the antibiotic prophylaxis use in adult heart transplantation in France.', 'detailedDescription': "In adult heart transplantation, clinical situations differ between patients (elective, emergency, redux surgery, ventricular assisting device or extracorporeal live saving). At investigator's knowledge, there is not recommendations in France about antibiotic prophylaxis in adult heart transplantation. So, investigators aimed to study the antibiotic prophylaxis use in adult heart transplantation in France.\n\nInvestigators conduct a French national survey about antibiotic prophylaxis used in adult heart transplantation center. Clinical situations such as elective, emergency, redux surgery, ventricular assisting device or extracorporeal live saving are investigated.\n\nStudy was performed after Institutional approval was obtained from the local Ethics Committee (Comite de Protection des Personnes Nord Ouest III). An electronic survey was sent to all French adult heart transplantation centers (22) on march 1st, 2015. Reminders were planned on week 2 and 4 after initial sending. On june 2015, nonresponding centers were contacted by phone. Data were collected by a single investigator."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All French centers perfoming adult heart transplantation in 2015.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All French centers performing adult heart transplantation in 2015\n\nExclusion Criteria:\n\n* not responding center\n* no adult heart transplantation'}, 'identificationModule': {'nctId': 'NCT02479503', 'acronym': 'ATC', 'briefTitle': 'Antibiotic Prophylaxis in Adult Heart Transplantation: a French National Survey', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Antibiotic Prophylaxis in Adult Heart Transplantation: a French National Survey', 'orgStudyIdInfo': {'id': 'ATC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'French Adult Heart Transplantation Center', 'description': 'All center performing adult heart transplantation in France in 2015.', 'interventionNames': ['Procedure: Antibiotic prophylaxis in adult heart transplantation']}], 'interventions': [{'name': 'Antibiotic prophylaxis in adult heart transplantation', 'type': 'PROCEDURE', 'armGroupLabels': ['French Adult Heart Transplantation Center']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'state': 'Normandy', 'country': 'France', 'facility': 'Caen University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}