SEIFEM 2010: Pre-hospital Risk Factors for Invasive Fungal Infection

Sponsor

Catholic University of the Sacred Heart (Other)

Overall Status

Unknown status

CT.gov ID

NCT01315925

Collaborator

(none)

1,000

Enrollment

Locations

23.8

Patients Per Site

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia Aspergillosis Candidiasis Mycoses

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 Start Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Newly disgnosed AML 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.

Arm

Intervention/Treatment

Newly disgnosed AML

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.

Outcome Measures

Primary Outcome Measures

Incidence of Invasive fungal infections [30th day after the end of first line chemotherapy]
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 Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Ancona	Ancona	AN	Italy
2	University of Bary	Bari	BA	Italy
3	University of Bologna	Bologna	BO	Italy
4	University of Firenze	Firenze	FI	Italy
5	Tricase Hospital	Tricase	LE	Italy
6	Niguarda Hospital	Milano	MI	Italy
7	Catholic University	Rome	RM	Italy	00168
8	IFO	Rome	RM	Italy
9	S.Camillo Hospital	Rome	RM	Italy
10	S.Giovanni Hospital	Rome	RM	Italy
11	University of Tor Vergata	Rome	RM	Italy
12	Le Molinette Hospital	Torino	TO	Italy
13	Hospital of Brescia	Brescia		Italy
14	University of Cagliari	Cagliari		Italy
15	Catholic University	Campobasso		Italy
16	Cuneo Hospital	Cuneo		Italy
17	Istotuto Meyer	Firenze		Italy
18	Gaslini Hospital	Genova		Italy
19	La Spezia Hospital	La Spezia		Italy
20	Lecce Hospital	Lecce		Italy
21	Lecce Pediatric Hospital	Lecce		Italy
22	University of Modena e Reggio	Modena		Italy
23	Monza Hospital	Monza		Italy
24	San Gerardo Hospital	Monza		Italy
25	"Federico II" University	Napoli		Italy
26	Cardarelli Hospital	Napoli		Italy
27	Pausilion Hospital	Napoli		Italy
28	University of Palermo	Palermo		Italy
29	University of Parma	Parma		Italy
30	S.Matteo Hospital, Department of Hematology	Pavia		Italy
31	S.Matteo Hospital, Department of Medicine	Pavia		Italy
32	University of Perugia, Pediatric Hematology	Perugia		Italy
33	University of Perugia	Perugia		Italy
34	Pescara Hospital	Pescara		Italy
35	Reggio Calabria Hospital	Reggio Calabria		Italy
36	Reggio Emilia Hospital	Reggio Emilia		Italy
37	"Padre Pio" Hospital	San Giovanni Rotondo		Italy
38	Regina Margherita Hospital	Torino		Italy
39	S.Anna Hospital	Torino		Italy
40	University of Udine	Udine		Italy
41	University of Verona	Verona		Italy
42	Verona Hospital	Verona		Italy