Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2026-01-31 @ 2:40 AM
Study NCT ID:
NCT02451592
Status:
COMPLETED
Last Update Posted:
2016-10-20
First Post:
2015-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fungemia in Hematologic Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D016469', 'term': 'Fungemia'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D000072742', 'term': 'Invasive Fungal Infections'}, {'id': 'D009181', 'term': 'Mycoses'}, {'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': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-19', 'studyFirstSubmitDate': '2015-05-13', 'studyFirstSubmitQcDate': '2015-05-21', 'lastUpdatePostDateStruct': {'date': '2016-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of fungemia outbreak during antifungal prophylaxis', 'timeFrame': 'Since 30 days average before fungemia onset'}], 'secondaryOutcomes': [{'measure': 'Mortality from fungemia', 'timeFrame': 'After 30 days from fungemia onset'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fungemia', 'Hematologic malignancies'], 'conditions': ['Acute Leukemia', 'Chronic Leukemia', 'Multiple Myeloma', 'Lymphoma']}, 'referencesModule': {'references': [{'pmid': '16885047', 'type': 'BACKGROUND', 'citation': 'Pagano L, Caira M, Candoni A, Offidani M, Fianchi L, Martino B, Pastore D, Picardi M, Bonini A, Chierichini A, Fanci R, Caramatti C, Invernizzi R, Mattei D, Mitra ME, Melillo L, Aversa F, Van Lint MT, Falcucci P, Valentini CG, Girmenia C, Nosari A. The epidemiology of fungal infections in patients with hematologic malignancies: the SEIFEM-2004 study. Haematologica. 2006 Aug;91(8):1068-75.'}, {'pmid': '17918077', 'type': 'BACKGROUND', 'citation': 'Pagano L, Caira M, Nosari A, Van Lint MT, Candoni A, Offidani M, Aloisi T, Irrera G, Bonini A, Picardi M, Caramatti C, Invernizzi R, Mattei D, Melillo L, de Waure C, Reddiconto G, Fianchi L, Valentini CG, Girmenia C, Leone G, Aversa F. Fungal infections in recipients of hematopoietic stem cell transplants: results of the SEIFEM B-2004 study--Sorveglianza Epidemiologica Infezioni Fungine Nelle Emopatie Maligne. Clin Infect Dis. 2007 Nov 1;45(9):1161-70. doi: 10.1086/522189. Epub 2007 Sep 26.'}, {'pmid': '22955439', 'type': 'BACKGROUND', 'citation': 'Pagano L, Caira M, Candoni A, Aversa F, Castagnola C, Caramatti C, Cattaneo C, Delia M, De Paolis MR, Di Blasi R, Di Caprio L, Fanci R, Garzia M, Martino B, Melillo L, Mitra ME, Nadali G, Nosari A, Picardi M, Potenza L, Salutari P, Trecarichi EM, Tumbarello M, Verga L, Vianelli N, Busca A; SEIFEM Group. Evaluation of the practice of antifungal prophylaxis use in patients with newly diagnosed acute myeloid leukemia: results from the SEIFEM 2010-B registry. Clin Infect Dis. 2012 Dec;55(11):1515-21. doi: 10.1093/cid/cis773. Epub 2012 Sep 5.'}, {'pmid': '25638805', 'type': 'BACKGROUND', 'citation': 'Caira M, Candoni A, Verga L, Busca A, Delia M, Nosari A, Caramatti C, Castagnola C, Cattaneo C, Fanci R, Chierichini A, Melillo L, Mitra ME, Picardi M, Potenza L, Salutari P, Vianelli N, Facchini L, Cesarini M, De Paolis MR, Di Blasi R, Farina F, Venditti A, Ferrari A, Garzia M, Gasbarrino C, Invernizzi R, Lessi F, Manna A, Martino B, Nadali G, Offidani M, Paris L, Pavone V, Rossi G, Spadea A, Specchia G, Trecarichi EM, Vacca A, Cesaro S, Perriello V, Aversa F, Tumbarello M, Pagano L; SEIFEM Group (Sorveglianza Epidemiologica Infezioni Fungine in Emopatie Maligne). Pre-chemotherapy risk factors for invasive fungal diseases: prospective analysis of 1,192 patients with newly diagnosed acute myeloid leukemia (SEIFEM 2010-a multicenter study). Haematologica. 2015 Feb;100(2):284-92. doi: 10.3324/haematol.2014.113399.'}, {'pmid': '24108614', 'type': 'BACKGROUND', 'citation': 'Bassetti M, Merelli M, Righi E, Diaz-Martin A, Rosello EM, Luzzati R, Parra A, Trecarichi EM, Sanguinetti M, Posteraro B, Garnacho-Montero J, Sartor A, Rello J, Tumbarello M. Epidemiology, species distribution, antifungal susceptibility, and outcome of candidemia across five sites in Italy and Spain. J Clin Microbiol. 2013 Dec;51(12):4167-72. doi: 10.1128/JCM.01998-13. Epub 2013 Oct 9.'}, {'pmid': '19549221', 'type': 'BACKGROUND', 'citation': 'Pagano L, Fianchi L, Fanci R, Candoni A, Caira M, Posteraro B, Morselli M, Valentini CG, Farina G, Mitra ME, Offidani M, Sanguinetti M, Tosti ME, Nosari A, Leone G, Viale P. Caspofungin for the treatment of candidaemia in patients with haematological malignancies. Clin Microbiol Infect. 2010 Mar;16(3):298-301. doi: 10.1111/j.1469-0691.2009.02832.x. Epub 2009 Jun 22.'}, {'pmid': '10480286', 'type': 'BACKGROUND', 'citation': 'Pagano L, Antinori A, Ammassari A, Mele L, Nosari A, Melillo L, Martino B, Sanguinetti M, Equitani F, Nobile F, Carotenuto M, Morra E, Morace G, Leone G. Retrospective study of candidemia in patients with hematological malignancies. Clinical features, risk factors and outcome of 76 episodes. Eur J Haematol. 1999 Aug;63(2):77-85. doi: 10.1111/j.1600-0609.1999.tb01120.x.'}, {'pmid': '11120607', 'type': 'BACKGROUND', 'citation': 'Moore CB, Sayers N, Mosquera J, Slaven J, Denning DW. Antifungal drug resistance in Aspergillus. J Infect. 2000 Nov;41(3):203-20. doi: 10.1053/jinf.2000.0747. No abstract available.'}, {'pmid': '11901654', 'type': 'BACKGROUND', 'citation': 'Sanglard D, Odds FC. Resistance of Candida species to antifungal agents: molecular mechanisms and clinical consequences. Lancet Infect Dis. 2002 Feb;2(2):73-85. doi: 10.1016/s1473-3099(02)00181-0.'}, {'pmid': '24118322', 'type': 'BACKGROUND', 'citation': 'Nucci M, Marr KA, Vehreschild MJ, de Souza CA, Velasco E, Cappellano P, Carlesse F, Queiroz-Telles F, Sheppard DC, Kindo A, Cesaro S, Hamerschlak N, Solza C, Heinz WJ, Schaller M, Atalla A, Arikan-Akdagli S, Bertz H, Galvao Castro C Jr, Herbrecht R, Hoenigl M, Harter G, Hermansen NE, Josting A, Pagano L, Salles MJ, Mossad SB, Ogunc D, Pasqualotto AC, Araujo V, Troke PF, Lortholary O, Cornely OA, Anaissie E. Improvement in the outcome of invasive fusariosis in the last decade. Clin Microbiol Infect. 2014 Jun;20(6):580-5. doi: 10.1111/1469-0691.12409. Epub 2013 Nov 18.'}, {'pmid': '15815003', 'type': 'BACKGROUND', 'citation': "Girmenia C, Pagano L, Martino B, D'Antonio D, Fanci R, Specchia G, Melillo L, Buelli M, Pizzarelli G, Venditti M, Martino P; GIMEMA Infection Program. Invasive infections caused by Trichosporon species and Geotrichum capitatum in patients with hematological malignancies: a retrospective multicenter study from Italy and review of the literature. J Clin Microbiol. 2005 Apr;43(4):1818-28. doi: 10.1128/JCM.43.4.1818-1828.2005."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the risk factors for fungemia in a population of patients diagnosed with hematologic malignancies and eligible for chemotherapy.', 'detailedDescription': 'The coordinating center provides all participating centers with an epidemiologic form, in order to collect data in a comparable way. The requested informations include type of malignancy and its treatment, environmental expositions, laboratory work up, antifungal prophylaxis, clinical signs of infection, microbiological findings, antifungal therapy and outcome of infection at 30 days.\n\nThe planned sample size is about 300 patients to be recruited in 35 participating center over 5 years, in a retrospective-prospective fashion. Data check will be performed at the coordinating center. Missing data will be managed to minimize incomplete reports.\n\nStatistical analysis will be performed by an independent reviewer, in order to assess risk factors predictive of fungal infection and outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive adult and pediatric patients affected by hematologic malignancies and eligible to chemotherapy that develop fungemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with hematologic malignancies and eligible to chemotherapy\n\nExclusion Criteria:\n\n* Patients not eligible to chemotherapy'}, 'identificationModule': {'nctId': 'NCT02451592', 'briefTitle': 'Fungemia in Hematologic Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne'}, 'officialTitle': 'SEIFEM 2015: Fungemia in Hematologic Malignancies', 'orgStudyIdInfo': {'id': 'SEIFEM 2015'}}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'facility': 'Catholic University of Sacred Heart', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Livio Pagano, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Catholic University of Sacred Heart, Rome Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Hematology Professor', 'investigatorFullName': 'LIVIO PAGANO', 'investigatorAffiliation': 'Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne'}}}}