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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Catholic University of the Sacred Heart.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01315925
First received: March 15, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted

March 15, 2011
March 15, 2011
January 2010
Not Provided
Incidence of Invasive fungal infections [ Time Frame: 30th day after the end of first line chemotherapy ] [ Designated as safety issue: No ]
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).
Same as current
No Changes Posted
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Pre-hospital Risk Factors for Invasive Fungal Infection
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).

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

Adult and pediatric patients with newly diagnosed acute myeloid leukemia, both eligible and not eligible for intensive chemotherapy.

  • Acute Myeloid Leukemia
  • Aspergillosis
  • Candidiasis
  • Mycoses
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
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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
Both
Not Provided
No
Italy
 
NCT01315925
751/2009
Not Provided
Livio Pagano, MD, Catholic University of the Sacred Heart
Catholic University of the Sacred Heart
Not Provided
Not Provided
Catholic University of the Sacred Heart
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP