Pre-hospital Risk Factors for Invasive Fungal Infection (SEIFEM 2010)
|ClinicalTrials.gov Identifier: NCT01315925|
Recruitment Status : Unknown
Verified March 2011 by Catholic University of the Sacred Heart.
Recruitment status was: Recruiting
First Posted : March 16, 2011
Last Update Posted : March 16, 2011
|First Submitted Date||March 15, 2011|
|First Posted Date||March 16, 2011|
|Last Update Posted Date||March 16, 2011|
|Study Start Date||January 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||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||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Pre-hospital Risk Factors for Invasive Fungal Infection|
|Official Title||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 Design||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.|
|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||Unknown status|
|Original Estimated Enrollment||Same as current|
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||Italy|
|Removed Location Countries|
|Other Study ID Numbers||751/2009|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Livio Pagano, MD, Catholic University of the Sacred Heart|
|Study Sponsor||Catholic University of the Sacred Heart|
|PRS Account||Catholic University of the Sacred Heart|
|Verification Date||March 2011|