Pre-hospital Risk Factors for Invasive Fungal Infection (SEIFEM 2010)
Recruitment status was: Recruiting
|First Received Date ICMJE||March 15, 2011|
|Last Updated Date||March 15, 2011|
|Start Date ICMJE||January 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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).
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Pre-hospital Risk Factors for Invasive Fungal Infection|
|Official Title ICMJE||SEIFEM 2010: Epidemiological Survey on Possible Pre-Hospital Risk Factors for Developing Invasive Fungal Infections in Patients Affected by Acute Myeloid Leukemia|
|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).|
EPIDEMIOLOGICAL SURVEY ON POSSIBLE PRE-HOSPITAL RISK FACTORS FOR DEVELOPING INVASIVE FUNGAL INFECTIONS IN PATIENTS AFFECTED BY ACUTE MYELOID LEUKEMIA
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:
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:
At the time of a diagnosis of fungal infection data on the type of infection, treatment and course of infection will be evaluated.
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.
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 ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|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.|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||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.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE||1000|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Italy|
|Removed Location Countries|
|NCT Number ICMJE||NCT01315925|
|Other Study ID Numbers ICMJE||751/2009|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Livio Pagano, MD, Catholic University of the Sacred Heart|
|Study Sponsor ICMJE||Catholic University of the Sacred Heart|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|PRS Account||Catholic University of the Sacred Heart|
|Verification Date||March 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP