Ignite Creation Date:
2025-12-24 @ 11:55 AM
Ignite Modification Date:
2025-12-31 @ 1:34 AM
Study NCT ID:
NCT01236261
Status:
COMPLETED
Last Update Posted:
2013-04-23
First Post:
2010-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Population Study on Candidemia in Spain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016469', 'term': 'Fungemia'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D004198', 'term': 'Disease Susceptibility'}], 'ancestors': [{'id': 'D000072742', 'term': 'Invasive Fungal Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Fungal strains obtained from blood cultures.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 730}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-22', 'studyFirstSubmitDate': '2010-11-05', 'studyFirstSubmitQcDate': '2010-11-05', 'lastUpdatePostDateStruct': {'date': '2013-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Describe fungemia epidemiology in Spain', 'timeFrame': '1 year', 'description': 'Recollection of demographic variables (age, gender and ethnic origin); clinical variables (background diseases, other coinfections, treatment received, etc) and microbiological information of the isolate.'}], 'secondaryOutcomes': [{'measure': 'Describe differences among cities and institutions', 'timeFrame': '1 year', 'description': 'Analyze results in function of the city and hospital where the isolate was obtained (5 cities in Spain and 29 participating hospitals)'}, {'measure': 'Definition of risk factors', 'timeFrame': '1 year', 'description': 'Determine risk factors for:\n\n* bad clinical evolution\n* infection by a specific Candida species\n* fluconazole resistant isolate\n* fungemia persistency'}, {'measure': 'Determination of the fungal isolates susceptibility to fluconazole, voriconazole, caspofungine, anidulafungine, micafungine and anfotericine B', 'timeFrame': '1 year', 'description': 'Analysis of resistant strains percentage according to the threshold established by CLSI to each specific antifungal'}, {'measure': 'Correlation between fungemia with a diminished susceptibility fungal strain and clinical evolution', 'timeFrame': '1 year', 'description': 'Chi-square and Kaplan-Meier survival curves'}, {'measure': 'Correlation between reference and commercial microbiological methods', 'timeFrame': '1 year', 'description': 'Comparison of results when a reference or a commercial fungal identification and antifungal susceptibility method is used.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fungemia, fungal infection, susceptibility, antifungal'], 'conditions': ['Fungemia']}, 'referencesModule': {'references': [{'pmid': '26976872', 'type': 'DERIVED', 'citation': 'Puig-Asensio M, Fernandez-Ruiz M, Aguado JM, Merino P, Lora-Pablos D, Guinea J, Martin-Davila P, Cuenca-Estrella M, Almirante B. Propensity Score Analysis of the Role of Initial Antifungal Therapy in the Outcome of Candida glabrata Bloodstream Infections. Antimicrob Agents Chemother. 2016 May 23;60(6):3291-300. doi: 10.1128/AAC.00195-16. Print 2016 Jun.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to describe the epidemiology of fungal blood infections in Spain (with emphasis on the incidence, fungal species distribution and antifungal susceptibility). The study is to be performed in five big cities which represent different geographic areas: Barcelona, Bilbao, Madrid, Sevilla and Valencia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with Candida sp or other fungal isolate obtained from a blood sample (fungemia episode)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fungal isolate obtained from blood sample\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01236261', 'acronym': 'CANDIPOP', 'briefTitle': 'Prospective Population Study on Candidemia in Spain', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion SEIMC-GESIDA'}, 'officialTitle': 'Prospective Population Study on Candidemia in Spain (Estudio Poblacional Prospectivo Sobre Candidemia en España)', 'orgStudyIdInfo': {'id': 'GEMICOMED-GEIH 0109'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fungemia', 'description': 'Patients with a fungal isolate from a blood culture', 'interventionNames': ['Other: Non intervention']}], 'interventions': [{'name': 'Non intervention', 'type': 'OTHER', 'description': 'Non interventional study', 'armGroupLabels': ['Fungemia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08003', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08034', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Vall d'Hebrón", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic i Provincial', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08041', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08950', 'city': 'Esplugues de Llobregat', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Sant Joan de Dèu', 'geoPoint': {'lat': 41.37732, 'lon': 2.08809}}, {'zip': '28922', 'city': 'Alcorcón', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Fundación de Alcorcón', 'geoPoint': {'lat': 40.34582, 'lon': -3.82487}}, {'zip': '28006', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital de la Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28007', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Gregorio Marañon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28009', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital del Niño Jesús', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28032', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Infanta Leonor', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28034', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Ramon y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Fundación Jiménez Díaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28222', 'city': 'Majadahonda', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Puerta de Hierro Majadahonda', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'zip': '41930', 'city': 'Bormujos', 'state': 'Seville', 'country': 'Spain', 'facility': 'Hospital San Juan de Dios del Aljarafe', 'geoPoint': {'lat': 37.37358, 'lon': -6.07233}}, {'zip': '41009', 'city': 'Seville', 'state': 'Seville', 'country': 'Spain', 'facility': 'Hospital Virgen de Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41013', 'city': 'Seville', 'state': 'Seville', 'country': 'Spain', 'facility': 'Clínica Sagrado Corazón', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41013', 'city': 'Seville', 'state': 'Seville', 'country': 'Spain', 'facility': 'Hospital Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41014', 'city': 'Seville', 'state': 'Seville', 'country': 'Spain', 'facility': 'Hospital Nuestra Señora de Valme', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46009', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46010', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clínico de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46014', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital General de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46017', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Doctor Peset', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '48903', 'city': 'Barakaldo', 'state': 'Vizcaya', 'country': 'Spain', 'facility': 'Hospital de Cruces', 'geoPoint': {'lat': 43.29639, 'lon': -2.98813}}, {'zip': '48013', 'city': 'Basurto', 'state': 'Vizcaya', 'country': 'Spain', 'facility': 'Hospital de Basurto'}, {'zip': '48960', 'city': 'Galdakao', 'state': 'Vizcaya', 'country': 'Spain', 'facility': 'Hospital de Galdakao-Usansolo', 'geoPoint': {'lat': 43.23073, 'lon': -2.8429}}], 'overallOfficials': [{'name': 'Manuel Cuenca, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Instituto de Salud Carlos III'}, {'name': 'Belen Padilla, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Gregorio Marañon'}, {'name': 'Isabel Ruiz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Hospital Vall d'Hebron"}, {'name': 'Jose Garnacho-Montero, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Virgen del Rocio'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion SEIMC-GESIDA', 'class': 'OTHER'}, 'collaborators': [{'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}