A Prospective Registry for Febrile Events in Patients With Malignant Hemopathies or Subjected to Haematopoietic Stem Cell Transplant

Hema e-chart is an electronic case record that can be changed in real time and is based on the chronological organisation of the infective events and the therapies prescribed. It allows the collection of all personal, epidemiological, diagnostic and therapeutic data pertaining to the patient, processing it and analysing the results. Aims and objectives of the project The aims of this registry are: * To assess how many suspected fungal-related febrile episodes identify an infective fungal agent * To have a clear view of the diagnostic and therapeutic actions in the management of onco-haematological patients with suspected fungal-related febrile episodes * To assess the impact of anti-fungal therapy on the timing of chemotherapy and transplant planning * Perform drug-epidemiology relationship analyses, observe toxicity and interactions with antifungal therapies by means of the creation of a national database of fungal infections in patients affected by malignant haemopathies Design * A multicentre, prospective registry for monitoring invasive fungal infections in onco-haematological patients * Registration criteria: patients with newly diagnosed malignant haematological diseases (acute and chronic myeloid and lymphoid leukaemia, multiple myeloma, non-Hodgkin's and Hodgkin's lymphoma, aplastic anaemia, myelodysplastic syndromes), or patients who, as a result of onco-haematological pathologies, have undergone allogenic or autologous haematopoietic cell transplants, and have ongoing febrile episodes . The recording of consecutive febrile events is required * Data collection for each individual patient will be performed according to the method shown in the enclosed flow chart. In the case of a new episode for an existing patient, said new episode will be recorded in the same case record as a new event. All collected data will be coded into the database * Information relating to about 500 suspected fungal-related febrile events requiring antifungal therapy is expected to be collected from approximately 60 centres over the course of 18 months * Data collection for each event may be performed following the provision of written informed consent, which will be obtained from each patient participating in this health survey * The data collected will be handled and stored in full compliance with the Italian laws governing privacy * Hema e-chart is a non-interventional registry

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* patients with newly diagnosed malignant haematological diseases (acute and chronic myeloid and lymphoid leukaemia, multiple myeloma, non-Hodgkin's and Hodgkin's lymphoma, aplastic anaemia, myelodysplastic syndromes), or patients who, as a result of onco-haematological pathologies, have undergone allogenic or autologous haematopoietic cell transplants, and have ongoing febrile episodes

• BACKGROUNDPagano L, Girmenia C, Mele L, Ricci P, Tosti ME, Nosari A, Buelli M, Picardi M, Allione B, Corvatta L, D'Antonio D, Montillo M, Melillo L, Chierichini A, Cenacchi A, Tonso A, Cudillo L, Candoni A, Savignano C, Bonini A, Martino P, Del Favero A; GIMEMA Infection Program; Gruppo Italiano Malattie Ematologiche dell'Adulto. Infections caused by filamentous fungi in patients with hematologic malignancies. A report of 391 cases by GIMEMA Infection Program. Haematologica. 2001 Aug;86(8):862-70. PMID 11522544
• 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
• BACKGROUNDMartino R, Lopez R, Sureda A, Brunet S, Domingo-Albos A. Risk of reactivation of a recent invasive fungal infection in patients with hematological malignancies undergoing further intensive chemo-radiotherapy. A single-center experience and review of the literature. Haematologica. 1997 May-Jun;82(3):297-304. PMID 9234575
• RESULTPagano L, Caira M, Nosari A, Viale P, Rossi G, Aversa F; Italian Hema e-Chart Group. Continuous surveillance of invasive fungal infection: a realistic goal for the near future. Clin Infect Dis. 2009 Jun 15;48(12):1801; author reply 1801-3. doi: 10.1086/599229. No abstract available. PMID 19473094
• DERIVEDPagano L, Caira M, Nosari A, Cattaneo C, Fanci R, Bonini A, Vianelli N, Garzia MG, Mancinelli M, Tosti ME, Tumbarello M, Viale P, Aversa F, Rossi G; HEMA e-Chart Group. The use and efficacy of empirical versus pre-emptive therapy in the management of fungal infections: the HEMA e-Chart Project. Haematologica. 2011 Sep;96(9):1366-70. doi: 10.3324/haematol.2011.042598. Epub 2011 May 12. PMID 21565903