Fungemia in Hematologic Malignancies

NCT ID: NCT02451592

Last Updated: 2016-10-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2016-01-31

Brief Summary

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.

Detailed Description

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.

The 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.

Statistical analysis will be performed by an independent reviewer, in order to assess risk factors predictive of fungal infection and outcome.

Conditions

Acute Leukemia; Chronic Leukemia; Multiple Myeloma; Lymphoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with hematologic malignancies and eligible to chemotherapy

Exclusion Criteria

• Patients not eligible to chemotherapy

• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne

OTHER

Sponsor Role: lead

Responsible Party

LIVIO PAGANO

MD, Hematology Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Livio Pagano, Professor

Role: PRINCIPAL_INVESTIGATOR

Catholic University of Sacred Heart, Rome Italy

Locations

Catholic University of Sacred Heart

Rome, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 16885047 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17918077 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22955439 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25638805 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24108614 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19549221 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10480286 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11120607 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11901654 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24118322 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15815003 (View on PubMed)

Other Identifiers

SEIFEM 2015

Identifier Type: -

Identifier Source: org_study_id