Pre-hospital Risk Factors for Invasive Fungal Infection

Pre-hospital Risk Factors for Invasive Fungal Infection (SEIFEM 2010)
This study is currently recruiting participants.
Verified March 2011 by Catholic University of the Sacred Heart

First Received on March 15, 2011.  
No Changes Posted
Sponsor: Catholic University of the Sacred Heart
Information provided by: Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01315925
  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:

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.

 
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:

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 August 21, 2012

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