Fungemia in Hematologic Malignancies

Multiple Myeloma Clinical Trial

Official title:

SEIFEM 2015: Fungemia in Hematologic Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02451592
• Other study ID #: SEIFEM 2015
• Status: Completed
• Phase: N/A
• First received: May 13, 2015
• Last updated: October 19, 2016
• Start date: January 2011
• Est. completion date: January 2016

Study information

• Verified date: October 2016
• Source: Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 80 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with hematologic malignancies and eligible to chemotherapy

Exclusion Criteria:

• Patients not eligible to chemotherapy

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Leukemia
• Chronic Leukemia
• Fungemia
• Leukemia
• Lymphoma
• Multiple Myeloma

Locations

Country	Name	City	State
Italy	Catholic University of Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne

Country where clinical trial is conducted

Italy, 

References & Publications (11)

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. — View 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. — View 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. Review. — View Citation

Moore CB, Sayers N, Mosquera J, Slaven J, Denning DW. Antifungal drug resistance in Aspergillus. J Infect. 2000 Nov;41(3):203-20. Review. — View 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, Galvão Castro C Jr, Herbrecht R, Hoenigl M, Härter 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. — View 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. — View 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. — View 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. — View 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. Epub 2007 Sep 26. — View 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. — View 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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of fungemia outbreak during antifungal prophylaxis		Since 30 days average before fungemia onset	No
Secondary	Mortality from fungemia		After 30 days from fungemia onset	No