Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-03-01 @ 8:53 PM
Study NCT ID:
NCT02847234
Status:
UNKNOWN
Last Update Posted:
2016-07-28
First Post:
2016-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Associated With Complications of Cervical Necrotizing Fasciitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008480', 'term': 'Mediastinitis'}], 'ancestors': [{'id': 'D008477', 'term': 'Mediastinal Diseases'}, {'id': 'D013896', 'term': 'Thoracic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-25', 'studyFirstSubmitDate': '2016-07-25', 'studyFirstSubmitQcDate': '2016-07-25', 'lastUpdatePostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of mediastinitis', 'timeFrame': 'At the entry in ICU (Day 1)', 'description': 'Computed tomography (CT) is performed at admission. Mediastinitis is described on CT finding.'}], 'secondaryOutcomes': [{'measure': 'factors associated with mediastinitis', 'timeFrame': 'At the entry in ICU (Day 1)', 'description': 'Computed tomography (CT) is performed at admission. Mediastinitis is described on CT finding.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cervical necrotizing fasciitis', 'mediastinitis'], 'conditions': ['Cervical Necrotizing Fasciitis']}, 'descriptionModule': {'briefSummary': 'Cervical necrotizing fasciitis (CNF) is a rare but severe complication of pharyngeal or dental infections. The infection can rapidly descend into the mediastinum and lead to a life-threatening prognosis. Treatment consists of a multidisciplinary approach in intensive care with radiologist and with early and repeated surgical debridement. Anti-inflammatory drugs have been incriminated by authors in the development of necrotizing fasciitis. Recently, a single-center study demonstrated that pharyngeal source of CNF and oral glucocorticoid intake before admission was associated with the occurrence of mediastinitis.\n\nThe aim of the study is to assess the incidence and factors associated with CNF complications, in particular mediastinitis. Secondary outcome is to describe patient characteristics, medical and surgical management.\n\nMethods: A retrospective, observational, non-interventional multicentre study is conducted in nine intensive care units in France from January 2005 to December 2016.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient admitted in ICU for management of cervical necrotizing fasciitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patient admitted in ICU for management of cervical necrotizing fasciitis between 2005 and 2016.\n\nExclusion Criteria:\n\n* Patients admitted in ICU for management of cervical abscess without cervical necrotizing fasciitis\n* Age \\< 18 years'}, 'identificationModule': {'nctId': 'NCT02847234', 'briefTitle': 'Factors Associated With Complications of Cervical Necrotizing Fasciitis', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Factors Associated With Complications of Cervical Necrotizing Fasciitis', 'orgStudyIdInfo': {'id': '69HCL16_0500'}}, 'contactsLocationsModule': {'locations': [{'zip': '69003', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Myrtille Fouché, resident', 'role': 'CONTACT', 'email': 'myrtille_fouche@hotmail.com', 'phone': '(0)613782554', 'phoneExt': '+33'}, {'name': 'Thomas Rimmelé, MD, PHD', 'role': 'CONTACT', 'email': 'thomas.rimmele@chu-lyon.fr', 'phone': '(0)4 72 11 69 88', 'phoneExt': '+33'}], 'facility': 'Intensive Care unit, Edouard Herriot Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Thomas Rimmelé, MD PhD', 'role': 'CONTACT', 'email': 'thomas.rimmele@chu-lyon.fr', 'phone': '(0)4 72 11 69 88', 'phoneExt': '+33'}, {'name': 'Myrtille Fouché, Resident', 'role': 'CONTACT', 'email': 'myrtille_fouche@hotmail.com', 'phone': '(0)6 13 78 24 54', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Thomas Rimmelé, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intensive Care unit, Edouard Herriot Hospital, 69003 Lyon, FRANCE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}