Pre-hospital Risk Factors for Invasive Fungal Infection (SEIFEM 2010)

March 15, 2011 updated by: Catholic University of the Sacred Heart

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

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).

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy
        • Recruiting
        • Hospital of Brescia
        • Contact:
        • Sub-Investigator:
          • Chiara Cattaneo
      • Cagliari, Italy
      • Campobasso, Italy
        • Recruiting
        • Catholic University
        • Contact:
        • Principal Investigator:
          • Sergio Storti
      • Cuneo, Italy
        • Active, not recruiting
        • Cuneo Hospital
      • Firenze, Italy
      • Genova, Italy
      • La Spezia, Italy
      • Lecce, Italy
      • Lecce, Italy
        • Active, not recruiting
        • Lecce Pediatric Hospital
      • Modena, Italy
        • Recruiting
        • University of Modena e Reggio
        • Principal Investigator:
          • Mario Luppi
        • Contact:
      • Monza, Italy
      • Monza, Italy
        • Active, not recruiting
        • San Gerardo Hospital
      • Napoli, Italy
      • Napoli, Italy
        • Active, not recruiting
        • Cardarelli Hospital
      • Napoli, Italy
        • Active, not recruiting
        • Pausilion Hospital
      • Palermo, Italy
        • Recruiting
        • University of Palermo
      • Parma, Italy
      • Pavia, Italy
        • Recruiting
        • S.Matteo Hospital, Department of Hematology
        • Contact:
        • Principal Investigator:
          • Carlo Castagnola
      • Pavia, Italy
      • Perugia, Italy
        • Recruiting
        • University of Perugia, Pediatric Hematology
        • Contact:
      • Perugia, Italy
        • Recruiting
        • University Of Perugia
        • Contact:
        • Principal Investigator:
          • Franco Aversa
      • Pescara, Italy
      • Reggio Calabria, Italy
      • Reggio Emilia, Italy
      • San Giovanni Rotondo, Italy
      • Torino, Italy
        • Active, not recruiting
        • Regina Margherita Hospital
      • Torino, Italy
      • Udine, Italy
        • Recruiting
        • University of Udine
      • Verona, Italy
      • Verona, Italy
    • AN
    • BA
      • Bari, BA, Italy
        • Recruiting
        • University of Bary
        • Principal Investigator:
          • Giorgina Specchia
        • Contact:
        • Sub-Investigator:
          • Mario Delia
    • BO
      • Bologna, BO, Italy
        • Recruiting
        • University of Bologna
        • Contact:
        • Principal Investigator:
          • Nicola Vianelli
    • FI
      • Firenze, FI, Italy
        • Recruiting
        • University of Firenze
        • Contact:
        • Principal Investigator:
          • Rosa Fanci
    • LE
    • MI
    • RM
      • Rome, RM, Italy, 00168
        • Recruiting
        • Catholic University
        • Contact:
        • Principal Investigator:
          • Livio Pagano, MD
        • Sub-Investigator:
          • Morena Caira, MD
        • Sub-Investigator:
          • Mario Mancinelli, MD
      • Rome, RM, Italy
        • Active, not recruiting
        • IFO
      • Rome, RM, Italy
      • Rome, RM, Italy
      • Rome, RM, Italy
        • Recruiting
        • University of Tor Vergata
    • TO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Invasive fungal infections
Time Frame: 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).
30th day after the end of first line chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Study Registration Dates

First Submitted

March 15, 2011

First Submitted That Met QC Criteria

March 15, 2011

First Posted (Estimate)

March 16, 2011

Study Record Updates

Last Update Posted (Estimate)

March 16, 2011

Last Update Submitted That Met QC Criteria

March 15, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 751/2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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