Clinical trial · Observational
Pre-hospital Risk Factors for Invasive Fungal Infection
SEIFEM 2010: Epidemiological Survey on Possible Pre-Hospital Risk Factors for Developing Invasive Fungal Infections in Patients Affected by Acute Myeloid Leukemia
NCT01315925CI-TRIAL-00004571SEIFEM 2010unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
SEIFEM 2010 study is a prospective, multicenter registry designed to identify and analyze risk factors for developing an invasive fungal infection in patients with newly diagnosed Acute Myeloid Leukemia, with particular interest on pre-hospital risk factors (i.e. those related to normal activities of daily life, such as occupation, location and type of residence, consume of tobacco, alcohol and others).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Aspergillosis | — | UNRESOLVED | — |
| Candidiasis | — | UNRESOLVED | — |
| Mycoses | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Newly disgnosed AML
- description
- Adult and pediatric patients with newly diagnosed acute myeloid leukemia, both eligible and not eligible for intensive chemotherapy. Since this is a non-interventional study, therapeutic strategies remains related to local guidelines. Will be treated as cases all patients with acute leukemia in first induction developing an Invasive Fungal Infection according to international EORTC criteria for possible/probable/proven infections. Patients who do not develop the infection will be used as a control group.
Primary outcomes (1)
- measure
- Incidence of Invasive fungal infections
- timeFrame
- 30th day after the end of first line chemotherapy
- description
- To identify possible fungal infections sources for the period preceding the diagnosis of leukemia, in particular those related to normal activities of daily life (e.g. occupation, location and type of residence, consume of tobacco, alcohol or illicit drugs and others).
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * all newly diagnosed AML who accept to take part to the registry and sign an informed consent Exclusion Criteria: * relapsing/refractory AML * patients who do not sign informed consent
References
Publications (6)
- BACKGROUNDCaira M, Mancinelli M, Leone G, Pagano L. Invasive aspergillosis in acute leukemias: old and new risk factors and epidemiological trends. Med Mycol. 2011 Apr;49 Suppl 1:S13-6. doi: 10.3109/13693786.2010.509138. Epub 2010 Aug 26. PMID 20795761
- BACKGROUNDMuhlemann K, Wenger C, Zenhausern R, Tauber MG. Risk factors for invasive aspergillosis in neutropenic patients with hematologic malignancies. Leukemia. 2005 Apr;19(4):545-50. doi: 10.1038/sj.leu.2403674. PMID 15729382
- BACKGROUNDPagano L, Caira M, Candoni A, Offidani M, Martino B, Specchia G, Pastore D, Stanzani M, Cattaneo C, Fanci R, Caramatti C, Rossini F, Luppi M, Potenza L, Ferrara F, Mitra ME, Fadda RM, Invernizzi R, Aloisi T, Picardi M, Bonini A, Vacca A, Chierichini A, Melillo L, de Waure C, Fianchi L, Riva M, Leone G, Aversa F, Nosari A. Invasive aspergillosis in patients with acute myeloid leukemia: a SEIFEM-2008 registry study. Haematologica. 2010 Apr;95(4):644-50. doi: 10.3324/haematol.2009.012054. Epub 2009 Oct 22. PMID 19850903
- DERIVEDCaira 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 25638805
- DERIVEDPagano L, Verga L, Busca A, Martino B, Mitra ME, Fanci R, Ballanti S, Picardi M, Castagnola C, Cattaneo C, Nadali G, Nosari A, Candoni A, Caira M, Salutari P, Lessi F, Aversa F, Tumbarello M. Systemic antifungal treatment after posaconazole prophylaxis: results from the SEIFEM 2010-C survey. J Antimicrob Chemother. 2014 Nov;69(11):3142-7. doi: 10.1093/jac/dku227. Epub 2014 Jun 19.