Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
Study NCT ID:
NCT03450005
Status:
RECRUITING
Last Update Posted:
2023-12-12
First Post:
2018-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ECMM Candida Registry - CandiReg
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058365', 'term': 'Candidiasis, Invasive'}], 'ancestors': [{'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000072742', 'term': 'Invasive Fungal Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'fungal culture'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-11', 'studyFirstSubmitDate': '2018-02-02', 'studyFirstSubmitQcDate': '2018-02-22', 'lastUpdatePostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence', 'timeFrame': 'up to 100 weeks', 'description': 'To describe the global incidence of invasive Candida infection'}, {'measure': 'Mortality', 'timeFrame': 'up to 100 weeks', 'description': 'To describe the global mortality of invasive Candida infection'}, {'measure': 'Molecular characteristics of Candida auris', 'timeFrame': 'At 90 Days from diagnosis', 'description': 'To describe the molecular characteristics of Candida auris'}, {'measure': 'Susceptibility testing', 'timeFrame': 'At 90 Days from diagnosis', 'description': 'To describe the susceptibility of Candida auris'}, {'measure': 'Resistance development', 'timeFrame': 'up to 100 weeks', 'description': 'To describe the resistance development of Candida auris'}], 'secondaryOutcomes': [{'measure': 'Treatment efficacy of invasive candida infections', 'timeFrame': 'At 90 Days from diagnosis', 'description': 'Number of participants with treatment failure'}, {'measure': 'Treatment efficacy of invasive candida infections', 'timeFrame': 'At 90 Days from diagnosis', 'description': 'Number of participants with stable disease'}, {'measure': 'Treatment efficacy of invasive candida infections', 'timeFrame': 'At 90 Days from diagnosis', 'description': 'Number of participants with partial response'}, {'measure': 'Treatment efficacy of invasive candida infections', 'timeFrame': 'At 90 Days from diagnosis', 'description': 'Number of participants with complete response'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Invasive Candidiases']}, 'descriptionModule': {'briefSummary': 'The objective of the European Confederation of Medical Mycology - ECMM Candida Registry (CandiReg) is to overcome the lack of knowledge on epidemiology, clinical course, and molecular characteristics of invasive infections due to invasive Candida infections and to function as a platform for future studies and in case of outbreaks.', 'detailedDescription': 'The specific objectives are:\n\nTo describe the global incidence of invasive Candida infection To monitor trends globally and locally over time To define patient risk groups To assess antifungal resistance among Candida spp. causing invasive diseases worldwide To assess attributable mortality of invasive Candida infection To assess incremental costs associated with invasive Candida infection\n\nTo describe the clinical pattern of disease To document diagnostic procedures performed for confirmation of diagnosis To describe first-line and salvage treatment regimens applied, guideline adherence, their efficacy and impact on patient survival To inform consensus guidelines To develop clinical screening and diagnostic procedures\n\nSet up of a collection of isolates with molecular characterization and evaluation of resistance genes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Invasive infections caused by Candida species', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cultural, histopathological, antigen or DNA evidence of invasive fungal infection with Candida species.\n* Hepatosplenic candidiasis with signs of disseminated Candida infection without culture, histological or microscopic evidence\n* Case control\n\nMatching procedure for controls:\n\nIn part, controls will be included at the same hospitals that include cases (i.e. each one control per case, both in the same hospital).\n\nControls will be matched by demographics, underlying diseases and risk factors as well as duration of hospitalization\n\nExclusion Criteria:\n\n\\- Colonization or other non-invasive infection, including superficial skin infections, candiduria without dissemination or Candida spp. in stool.'}, 'identificationModule': {'nctId': 'NCT03450005', 'acronym': 'CandiReg', 'briefTitle': 'ECMM Candida Registry - CandiReg', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'ECMM Candida Registry - CandiReg', 'orgStudyIdInfo': {'id': 'Candi001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'emerging Candida isolates', 'description': 'Web-based registry of invasive infections by Candida species'}]}, 'contactsLocationsModule': {'locations': [{'zip': '50937', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Oliver Cornely, MD', 'role': 'CONTACT', 'email': 'oliver.cornely@uk-koeln.de', 'phone': '+49 221 478', 'phoneExt': '85523'}, {'name': 'Philipp Koehler, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'centralContacts': [{'name': 'Oliver Cornely, MD', 'role': 'CONTACT', 'email': 'oliver.cornely@uk-koeln.de', 'phone': '+49 221 478', 'phoneExt': '85223'}], 'overallOfficials': [{'name': 'Oliver Cornely, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Cologne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Oliver Cornely, MD', 'investigatorAffiliation': 'University of Cologne'}}}}