Pre-hospital Risk Factors for Invasive Fungal Infection

Acute Myeloid Leukemia Clinical Trial

— SEIFEM 2010  

Official title:

SEIFEM 2010: Epidemiological Survey on Possible Pre-Hospital Risk Factors for Developing Invasive Fungal Infections in Patients Affected by Acute Myeloid Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01315925
• Other study ID #: 751/2009
• 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
• 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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Aspergillosis
• Candidiasis
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Mycoses

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