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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01315925
Other study ID # 751/2009
Secondary ID
Status Recruiting
Phase N/A
First received March 15, 2011
Last updated March 15, 2011
Start date January 2010

Study information

Verified date March 2011
Source Catholic University of the Sacred Heart
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Italy University of Ancona Ancona AN
Italy University of Bary Bari BA
Italy University of Bologna Bologna BO
Italy Hospital of Brescia Brescia
Italy University of Cagliari Cagliari
Italy Catholic University Campobasso
Italy Cuneo Hospital Cuneo
Italy Istotuto Meyer Firenze
Italy University of Firenze Firenze FI
Italy Gaslini Hospital Genova
Italy La Spezia Hospital La Spezia
Italy Lecce Hospital Lecce
Italy Lecce Pediatric Hospital Lecce
Italy Niguarda Hospital Milano MI
Italy University of Modena e Reggio Modena
Italy Monza Hospital Monza
Italy San Gerardo Hospital Monza
Italy "Federico II" University Napoli
Italy Cardarelli Hospital Napoli
Italy Pausilion Hospital Napoli
Italy University of Palermo Palermo
Italy University of Parma Parma
Italy S.Matteo Hospital, Department of Hematology Pavia
Italy S.Matteo Hospital, Department of Medicine Pavia
Italy University of Perugia Perugia
Italy University of Perugia, Pediatric Hematology Perugia
Italy Pescara Hospital Pescara
Italy Reggio Calabria Hospital Reggio Calabria
Italy Reggio Emilia Hospital Reggio Emilia
Italy Catholic University Rome RM
Italy IFO Rome RM
Italy S.Camillo Hospital Rome RM
Italy S.Giovanni Hospital Rome RM
Italy University of Tor Vergata Rome RM
Italy "Padre Pio" Hospital San Giovanni Rotondo
Italy Le Molinette Hospital Torino TO
Italy Regina Margherita Hospital Torino
Italy S.Anna Hospital Torino
Italy Tricase Hospital Tricase LE
Italy University of Udine Udine
Italy University of Verona Verona
Italy Verona Hospital Verona

Sponsors (1)

Lead Sponsor Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

Mühlemann K, Wenger C, Zenhäusern R, Täuber MG. Risk factors for invasive aspergillosis in neutropenic patients with hematologic malignancies. Leukemia. 2005 Apr;19(4):545-50. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Invasive fungal infections 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). 30th day after the end of first line chemotherapy No
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