Clinical trial NCT01315925: Pre-hospital Risk Factors for Invasive Fungal Infection
Official title: SEIFEM 2010: Epidemiological Survey on Possible Pre-Hospital Risk Factors for Developing Invasive Fungal Infections in Patients Affected by Acute Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myeloid Leukemia
Aspergillosis
Candidiasis
Mycoses
Keywords: Acute myeloid leukemia
invasive fungal infection
Aspergillosis
candidiasis
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2011-03-16
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult and pediatric patients with newly diagnosed acute myeloid leukemia, both eligible and not eligible for intensive chemotherapy.

Brief summary: 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).

Detailed description: SEIFEM 2010:

EPIDEMIOLOGICAL SURVEY ON POSSIBLE PRE-HOSPITAL RISK FACTORS FOR DEVELOPING INVASIVE FUNGAL INFECTIONS IN PATIENTS AFFECTED BY ACUTE MYELOID LEUKEMIA

Background:

In two different multicenter surveys conducted in Italy from 1988-1997 and 1999-2003, (Invasive Fungal Infections) IFIs were found to be a frequent cause of morbidity and mortality in patients treated with conventional chemotherapies, particularly in those suffering from acute myeloid leukemia (AML).

In general, the major factors that have been recognized as influencing the likelihood of invasive fungal infection are the patient's immune status, the degree of any organ damage (e.g., mucositis), and overall microbial exposure (i.e., colonization, environment, and prior infection). Since the 1990s, different risk-stratification strategies have been evaluated in order to identify those patients who may benefit from intensive prophylactic and diagnostic measures. However, despite having similar risk profiles, only a subset of AML patients will develop an IFI. One of the most exciting recent advances in the understanding of the epidemiology of IFIs is the recognition of the complexity of the host and the identification of new host-related risk factors.

Aim of this study is 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.

Aims and objective:

* To identify high risk subjects that can take advantage of an antifungal prophylaxis or an early antifungal treatment (preemptive treatment).
* 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).
* To analyze hospital-related sources of fungal infection, from well known predisposing factors (i.e. duration and severity of neutropenia) to other like central venous catheter, urinary catheter, comorbidities, etc.
* To analyze the impact of both the prophylactic regimen adopted and the antifungal treatment.

Design:

* Prospective, multicenter, observational and clinical-epidemiological study.
* The study is expected to enroll at least 500 patients with newly diagnosed acute myeloid leukemia, those eligible for treatment and those not eligible, within 2 years or until the achievement of a statistically evaluable number of cases.
* SEIFEM 2010 is a noninterventional registry and therefore there will not be any any change physicians' diagnostic and therapeutic choices, that remain related to local guidelines.
* Every patient who accept to take part to the study, will be asked to read and sign an informed consent.
* An apposite form, with a detailed epidemiological section, should be compiled by clinicians for each enrolled patient.
* A complete information page on the study is supplied to each patient enrolled.

Data collection:

In the questionnaire, possible risk factors for invasive fungal infections, prior to the onset of acute leukemia, are evaluated. The module consists of several sections:

* Personal information (age, sex, observation time of the case, AML subtype, performance status at admission), patient data will be anonymous.
* Comorbidities (diabetes, chronic renal failure, COPD, chronic liver disease, previous TBC)
* A section compiled by the patient about possible risk factors related to the daily living habits (location and type of residence, profession, hobbies, pets, personal hygiene, ambiental exposures, consume of tobacco, alcohol or illicit drugs and others)
* A second part of the form will be compiled at the time of evaluation after induction chemotherapy (between 30 and 40 days after chemotherapy) or, for those not suitable for conventional treatment, 30-40 days after diagnosis.

At the time of a diagnosis of fungal infection data on the type of infection, treatment and course of infection will be evaluated.

Eligibility:

Adult and pediatric patients with newly diagnosed acute myeloid leukemia, both eligible and not eligible for intensive chemotherapy. Since this is a noninterventional 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.

Participating centers:

Forty-three Italian divisions of Hematology will take part to the study, distributed among universities and highly specialized hospitals located throughout the country.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Invasive fungal infections
timeFrame: 30th day after the end of first line chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: University of Ancona
state: AN
city: Bari
country: Italy
facility: University of Bary
state: BA
city: Bologna
country: Italy
facility: University of Bologna
state: BO
city: Firenze
country: Italy
facility: University of Firenze
state: FI
city: Tricase
country: Italy
facility: Tricase Hospital
state: LE
city: Milano
country: Italy
facility: Niguarda Hospital
state: MI
city: Rome
country: Italy
facility: Catholic University
state: RM
city: Rome
country: Italy
facility: IFO
state: RM
city: Rome
country: Italy
facility: S.Camillo Hospital
state: RM
city: Rome
country: Italy
facility: S.Giovanni Hospital
state: RM
city: Rome
country: Italy
facility: University of Tor Vergata
state: RM
city: Torino
country: Italy
facility: Le Molinette Hospital
state: TO
city: Brescia
country: Italy
facility: Hospital of Brescia
city: Cagliari
country: Italy
facility: University of Cagliari
city: Campobasso
country: Italy
facility: Catholic University
city: Cuneo
country: Italy
facility: Cuneo Hospital
city: Firenze
country: Italy
facility: Istotuto Meyer
city: Genova
country: Italy
facility: Gaslini Hospital
city: La Spezia
country: Italy
facility: La Spezia Hospital
city: Lecce
country: Italy
facility: Lecce Hospital
city: Lecce
country: Italy
facility: Lecce Pediatric Hospital
city: Modena
country: Italy
facility: University of Modena e Reggio
city: Monza
country: Italy
facility: Monza Hospital
city: Monza
country: Italy
facility: San Gerardo Hospital
city: Napoli
country: Italy
facility: "Federico II" University
city: Napoli
country: Italy
facility: Cardarelli Hospital
city: Napoli
country: Italy
facility: Pausilion Hospital
city: Palermo
country: Italy
facility: University of Palermo
city: Parma
country: Italy
facility: University of Parma
city: Pavia
country: Italy
facility: S.Matteo Hospital, Department of Hematology
city: Pavia
country: Italy
facility: S.Matteo Hospital, Department of Medicine
city: Perugia
country: Italy
facility: University of Perugia, Pediatric Hematology
city: Perugia
country: Italy
facility: University of Perugia
city: Pescara
country: Italy
facility: Pescara Hospital
city: Reggio Calabria
country: Italy
facility: Reggio Calabria Hospital
city: Reggio Emilia
country: Italy
facility: Reggio Emilia Hospital
city: San Giovanni Rotondo
country: Italy
facility: "Padre Pio" Hospital
city: Torino
country: Italy
facility: Regina Margherita Hospital
city: Torino
country: Italy
facility: S.Anna Hospital
city: Udine
country: Italy
facility: University of Udine
city: Verona
country: Italy
facility: University of Verona
city: Verona
country: Italy
facility: Verona Hospital
Study officials:
References:
citation: Caira 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.
citation: Muhlemann 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.
citation: Pagano 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.
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.
citation: Pagano 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.
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.