Pre-hospital Risk Factors for Invasive Fungal Infection - Full Text View

Purpose

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).

Condition
Acute Myeloid Leukemia Aspergillosis Candidiasis Mycoses

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	SEIFEM 2010: Epidemiological Survey on Possible Pre-Hospital Risk Factors for Developing Invasive Fungal Infections in Patients Affected by Acute Myeloid Leukemia

Resource links provided by NLM:

Genetics Home Reference related topics: familial acute myeloid leukemia with mutated CEBPA

MedlinePlus related topics: Acute Myeloid Leukemia Aspergillosis Fungal Infections Leukemia Molds Yeast Infections

U.S. FDA Resources

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:

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).

Estimated Enrollment:	1000
Study Start Date:	January 2010

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.

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.

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315925

Locations

Italy
University of Ancona	Recruiting
Ancona, AN, Italy
Contact: Massimo Offidani, MD m.offidani@ao-umbertoprimo.marche.it
Principal Investigator: Massimo Offidani, MD
University of Bary	Recruiting
Bari, BA, Italy
Contact: Mario Delia, MD mario.delia74@gmail.com
Principal Investigator: Giorgina Specchia
Sub-Investigator: Mario Delia
University of Bologna	Recruiting
Bologna, BO, Italy
Contact: Nicola Vianelli nicola.vianelli@unibo.it
Principal Investigator: Nicola Vianelli
University of Firenze	Recruiting
Firenze, FI, Italy
Contact: Rosa Fanci, MD r.fanci@dac.unifi.it
Principal Investigator: Rosa Fanci
Tricase Hospital	Recruiting
Tricase, LE, Italy
Contact: Vincenzo Pavone salentoematologia@piafondazionepanico.it
Niguarda Hospital	Recruiting
Milano, MI, Italy
Contact: Annamaria Nosari, MD annamaria.nosari@ospedaleniguarda.it
Principal Investigator: Annamaria Nosari, MD
Catholic University	Recruiting
Rome, RM, Italy, 00168
Contact: Livio Pagano, MD +390630154180 lpagano@rm.unicatt.it
Principal Investigator: Livio Pagano, MD
Sub-Investigator: Morena Caira, MD
Sub-Investigator: Mario Mancinelli, MD
University of Tor Vergata	Recruiting
Rome, RM, Italy
Contact: Adriano Venditti adriano.venditti@uniroma2.it
S.Giovanni Hospital	Recruiting
Rome, RM, Italy
Contact: Anna Chierichini annachierichini@hotmail.com
S.Camillo Hospital	Recruiting
Rome, RM, Italy
Contact: Maria Grazia Garzia mariagraziagarzia@hotmail.com
IFO	Active, not recruiting
Rome, RM, Italy
Le Molinette Hospital	Recruiting
Torino, TO, Italy
Contact: Alessandro Busca abusca@molinette.piemonte.it
Hospital of Brescia	Recruiting
Brescia, Italy
Contact: Chiara Cattaneo, MD chiara.cattaneo@libero.it
Sub-Investigator: Chiara Cattaneo
Principal Investigator: Giuseppe Rossi
University of Cagliari	Recruiting
Cagliari, Italy
Contact: Adriana Vacca vaccaadriana@gmail.com
Catholic University	Recruiting
Campobasso, Italy
Contact: Cristina Gasbarrino gasbacri@virgilio.it
Principal Investigator: Sergio Storti
Cuneo Hospital	Active, not recruiting
Cuneo, Italy
Istotuto Meyer	Recruiting
Firenze, Italy
Contact: Desiree Caselli d.caselli@meyer.it
Gaslini Hospital	Recruiting
Genova, Italy
Contact: Elio Castagnola eliocastagnola@ospedale-gaslini.ge.it
La Spezia Hospital	Recruiting
La Spezia, Italy
Contact: Annunziata Manna annunziata.manna@asl5.liguria.it
Lecce Hospital	Recruiting
Lecce, Italy
Contact: De Paolis depaolis.ematolecce@libero.it
Lecce Pediatric Hospital	Active, not recruiting
Lecce, Italy
University of Modena e Reggio	Recruiting
Modena, Italy
Contact: Mario Luppi mluppi@unimore.it
Principal Investigator: Mario Luppi
Monza Hospital	Recruiting
Monza, Italy
Contact: Luisa Verga luisa.verga@libero.it
San Gerardo Hospital	Active, not recruiting
Monza, Italy
Cardarelli Hospital	Active, not recruiting
Napoli, Italy
"Federico II" University	Recruiting
Napoli, Italy
Contact: Marco Picardi, MD picardi@ceinge.unina.it
Pausilion Hospital	Active, not recruiting
Napoli, Italy
University of Palermo	Recruiting
Palermo, Italy
Contact: Maria Enza Mitra memitra@yahoo.com
Principal Investigator: Maria Enza Mitra
University of Parma	Recruiting
Parma, Italy
Contact: Cecilia Caramatti cecilia.caramatti@unipr.it
S.Matteo Hospital, Department of Medicine	Recruiting
Pavia, Italy
Contact: Rosangela Invernizzi r.invernizzi@smatteo.pv.it
S.Matteo Hospital, Department of Hematology	Recruiting
Pavia, Italy
Contact: Carlo Castagnola castagnola@smatteo.pv.it
Principal Investigator: Carlo Castagnola
University of Perugia, Pediatric Hematology	Recruiting
Perugia, Italy
Contact: Franco Aversa aversa@unipg.it
University of Perugia	Recruiting
Perugia, Italy
Contact: Franco Aversa aversa@unipg.it
Principal Investigator: Franco Aversa
Pescara Hospital	Recruiting
Pescara, Italy
Contact: Prassede Salutari prassede.salutari@email.it
Reggio Calabria Hospital	Recruiting
Reggio Calabria, Italy
Contact: Bruno Martino brunmartin@libero.it
Reggio Emilia Hospital	Recruiting
Reggio Emilia, Italy
Contact: Alessandro Bonini Alessandro.Bonini@asmn.re.it
"Padre Pio" Hospital	Recruiting
San Giovanni Rotondo, Italy
Contact: Lorella Melillo l.melillo@operapadrepio.it
Regina Margherita Hospital	Active, not recruiting
Torino, Italy
S.Anna Hospital	Recruiting
Torino, Italy
Contact: Mareva Giacchino mareva.giacchino@unito.it
University of Udine	Recruiting
Udine, Italy
Contact: Anna Candoni candoni.anna@aoud.sanita.fvg.it
Verona Hospital	Recruiting
Verona, Italy
Contact: Simone Cesaro simone.cesaro@azosp.vr.it
University of Verona	Recruiting
Verona, Italy
Contact: Gianpaolo Nadali gianpaolo.nadali@univr.it

Sponsors and Collaborators

Catholic University of the Sacred Heart

More Information

Publications:

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. Epub 2010 Aug 26.

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.

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. Epub 2009 Oct 22.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pagano L, Caira M, Candoni A, Aversa F, Castagnola C, Caramatti C, Cattaneo C, Delia M, De Paolis MR, Di Blasi R, Di Caprio L, Fanci R, Garzia M, Martino B, Melillo L, Mitra ME, Nadali G, Nosari A, Picardi M, Potenza L, Salutari P, Trecarichi EM, Tumbarello M, Verga L, Vianelli N, Busca A; SEIFEM Group. Evaluation of the practice of antifungal prophylaxis use in patients with newly diagnosed acute myeloid leukemia: results from the SEIFEM 2010-B registry. Clin Infect Dis. 2012 Dec;55(11):1515-21. doi: 10.1093/cid/cis773. Epub 2012 Sep 5.

Responsible Party:	Livio Pagano, MD, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:	NCT01315925 History of Changes
Other Study ID Numbers:	751/2009
Study First Received:	March 15, 2011
Last Updated:	March 15, 2011
Health Authority:	Italy: Ethics Committee

Keywords provided by Catholic University of the Sacred Heart:

Acute myeloid leukemia
invasive fungal infection
Aspergillosis
candidiasis

Additional relevant MeSH terms:

Aspergillosis
Candidiasis
Leukemia
Leukemia, Myeloid, Acute

Leukemia, Myeloid
Mycoses
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013

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