Acute Myeloid LeukemiaSEIFEM 2010NCT01315925
Pre-hospital Risk Factors for Invasive Fungal Infection
An observational study of Acute Myeloid Leukemia and Aspergillosis, run by Catholic University of the Sacred Heart at 42 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myeloid Leukemia, Aspergillosis, Candidiasis
- How many people
- 1,000 participants
- Where
- 42 sitesItaly
- Study dates
- Jan 2010to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult and pediatric patients with newly diagnosed acute myeloid leukemia, both eligible and not eligible for intensive chemotherapy.
Who may be able to join
- all newly diagnosed AML who accept to take part to the registry and sign an informed consent
Who cannot join
- relapsing/refractory AML
- patients who do not sign informed consent
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
Italy42 sites, 35 recruiting
- Recruiting
University of Ancona
Ancona, AN
Massimo Offidani, MD, m.offidani@ao-umbertoprimo.marche.it
Massimo Offidani, MD
- Recruiting
University of Bary
Bari, BA
Mario Delia, MD, mario.delia74@gmail.com
Giorgina Specchia
- Recruiting
University of Bologna
Bologna, BO
Nicola Vianelli, nicola.vianelli@unibo.it
Nicola Vianelli
- Recruiting
Hospital of Brescia
Brescia
Chiara Cattaneo, MD, chiara.cattaneo@libero.it
Chiara Cattaneo
- Recruiting
University of Cagliari
Cagliari
Adriana Vacca, vaccaadriana@gmail.com
- Recruiting
Catholic University
Campobasso, Campobasso
Cristina Gasbarrino, gasbacri@virgilio.it
Sergio Storti
- Active, not recruiting
Cuneo Hospital
Cuneo
- Recruiting
University of Firenze
Florence, FI
Rosa Fanci, MD, r.fanci@dac.unifi.it
Rosa Fanci
- Recruiting
Istotuto Meyer
Florence
Desiree Caselli, d.caselli@meyer.it
- Recruiting
Gaslini Hospital
Genova
Elio Castagnola, eliocastagnola@ospedale-gaslini.ge.it
- Recruiting
La Spezia Hospital
La Spezia
Annunziata Manna, annunziata.manna@asl5.liguria.it
- Recruiting
Lecce Hospital
Lecce
De Paolis, depaolis.ematolecce@libero.it
- Active, not recruiting
Lecce Pediatric Hospital
Lecce
- Recruiting
Niguarda Hospital
Milan, MI
Annamaria Nosari, MD, annamaria.nosari@ospedaleniguarda.it
Annamaria Nosari, MD
- Recruiting
University of Modena e Reggio
Modena
Mario Luppi, mluppi@unimore.it
Mario Luppi
- Recruiting
Monza Hospital
Monza
Luisa Verga, luisa.verga@libero.it
- Active, not recruiting
San Gerardo Hospital
Monza
- Recruiting
"Federico II" University
Naples
Marco Picardi, MD, picardi@ceinge.unina.it
- Active, not recruiting
Cardarelli Hospital
Naples
- Active, not recruiting
Pausilion Hospital
Naples
- Recruiting
University of Palermo
Palermo
Maria Enza Mitra, memitra@yahoo.com
Maria Enza Mitra
- Recruiting
University of Parma
Parma
Cecilia Caramatti, cecilia.caramatti@unipr.it
- Recruiting
S.Matteo Hospital, Department of Hematology
Pavia
Carlo Castagnola, castagnola@smatteo.pv.it
Carlo Castagnola
- Recruiting
S.Matteo Hospital, Department of Medicine
Pavia
Rosangela Invernizzi, r.invernizzi@smatteo.pv.it
- Recruiting
University of Perugia, Pediatric Hematology
Perugia
Franco Aversa, aversa@unipg.it
- Recruiting
University of Perugia
Perugia
Franco Aversa, aversa@unipg.it
Franco Aversa
- Recruiting
Pescara Hospital
Pescara
Prassede Salutari, prassede.salutari@email.it
- Recruiting
Reggio Calabria Hospital
Reggio Calabria
Bruno Martino, brunmartin@libero.it
- Recruiting
Reggio Emilia Hospital
Reggio Emilia
Alessandro Bonini, Alessandro.Bonini@asmn.re.it
- Recruiting
Catholic University
Rome, RM, 00168
Livio Pagano, MD, +390630154180, lpagano@rm.unicatt.it
Livio Pagano, MD
- Active, not recruiting
IFO
Rome, RM
- Recruiting
S.Camillo Hospital
Rome, RM
Maria Grazia Garzia, mariagraziagarzia@hotmail.com
- Recruiting
S.Giovanni Hospital
Rome, RM
Anna Chierichini, annachierichini@hotmail.com
- Recruiting
University of Tor Vergata
Rome, RM
Adriano Venditti, adriano.venditti@uniroma2.it
- Recruiting
"Padre Pio" Hospital
San Giovanni Rotondo
Lorella Melillo, l.melillo@operapadrepio.it
- Recruiting
Le Molinette Hospital
Torino, TO
Alessandro Busca, abusca@molinette.piemonte.it
- Active, not recruiting
Regina Margherita Hospital
Torino
- Recruiting
S.Anna Hospital
Torino
Mareva Giacchino, mareva.giacchino@unito.it
- Recruiting
Tricase Hospital
Tricase, LE
Vincenzo Pavone, salentoematologia@piafondazionepanico.it
- Recruiting
University of Udine
Udine
Anna Candoni, candoni.anna@aoud.sanita.fvg.it
- Recruiting
University of Verona
Verona
Gianpaolo Nadali, gianpaolo.nadali@univr.it
- Recruiting
Verona Hospital
Verona
Simone Cesaro, simone.cesaro@azosp.vr.it
About this study
Official title: 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).
Read the detailed description
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.
- Conditions
- Acute Myeloid Leukemia, Aspergillosis, Candidiasis, Mycoses
- Keywords
- Acute myeloid leukemia, invasive fungal infection, Aspergillosis, candidiasis
- Medical subject headings
- Leukemia, Myeloid, Acute, Aspergillosis, Candidiasis, Mycoses, Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Invasive fungal infections
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).
Measured: 30th day after the end of first line chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315925
- Sponsor's protocol ID
- 751/2009
- Acronym
- SEIFEM 2010
- Status last verified
- Mar 2011
- First submitted
- 15 Mar 2011
- Last updated
- 16 Mar 2011
- Results posted
- No
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. doi: 10.3109/13693786.2010.509138. Epub 2010 Aug 26.
PubMed 20795761Muhlemann K, Wenger C, Zenhausern R, Tauber MG. Risk factors for invasive aspergillosis in neutropenic patients with hematologic malignancies. Leukemia. 2005 Apr;19(4):545-50. doi: 10.1038/sj.leu.2403674.
PubMed 15729382Pagano 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. doi: 10.3324/haematol.2009.012054. Epub 2009 Oct 22.
PubMed 19850903Caira M, Candoni A, Verga L, Busca A, Delia M, Nosari A, Caramatti C, Castagnola C, Cattaneo C, Fanci R, Chierichini A, Melillo L, Mitra ME, Picardi M, Potenza L, Salutari P, Vianelli N, Facchini L, Cesarini M, De Paolis MR, Di Blasi R, Farina F, Venditti A, Ferrari A, Garzia M, Gasbarrino C, Invernizzi R, Lessi F, Manna A, Martino B, Nadali G, Offidani M, Paris L, Pavone V, Rossi G, Spadea A, Specchia G, Trecarichi EM, Vacca A, Cesaro S, Perriello V, Aversa F, Tumbarello M, Pagano L; SEIFEM Group (Sorveglianza Epidemiologica Infezioni Fungine in Emopatie Maligne). Pre-chemotherapy risk factors for invasive fungal diseases: prospective analysis of 1,192 patients with newly diagnosed acute myeloid leukemia (SEIFEM 2010-a multicenter study). Haematologica. 2015 Feb;100(2):284-92. doi: 10.3324/haematol.2014.113399.
PubMed 25638805Pagano L, Verga L, Busca A, Martino B, Mitra ME, Fanci R, Ballanti S, Picardi M, Castagnola C, Cattaneo C, Nadali G, Nosari A, Candoni A, Caira M, Salutari P, Lessi F, Aversa F, Tumbarello M. Systemic antifungal treatment after posaconazole prophylaxis: results from the SEIFEM 2010-C survey. J Antimicrob Chemother. 2014 Nov;69(11):3142-7. doi: 10.1093/jac/dku227. Epub 2014 Jun 19.
PubMed 24948702Pagano 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.
PubMed 22955439
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEIFEM 2010: Epidemiological Survey on Possible Pre-Hospital Risk Factors for Developing Invasive Fungal Infections in Patients Affected by Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT01315925
- Acronym / sponsor ID
- SEIFEM 2010 / 751/2009
- Conditions
- Acute Myeloid Leukemia, Aspergillosis, Candidiasis, Mycoses
- Keywords
- Acute myeloid leukemia, invasive fungal infection, Aspergillosis, candidiasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Jan 2010
- First posted
- 16 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult and pediatric patients with newly diagnosed acute myeloid leukemia, both eligible and not eligible for intensive chemotherapy.
Key inclusion criteria (1 listed)
- all newly diagnosed AML who accept to take part to the registry and sign an informed consent
Key exclusion criteria (2 listed)
- relapsing/refractory AML
- patients who do not sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2011.
- Background: PubMed 20795761Caira 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. doi: 10.3109/13693786.2010.509138. Epub 2010 Aug 26.
- Background: PubMed 15729382Muhlemann K, Wenger C, Zenhausern R, Tauber MG. Risk factors for invasive aspergillosis in neutropenic patients with hematologic malignancies. Leukemia. 2005 Apr;19(4):545-50. doi: 10.1038/sj.leu.2403674.
- Background: PubMed 19850903Pagano 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. doi: 10.3324/haematol.2009.012054. Epub 2009 Oct 22.
- Derived from this study: PubMed 25638805Caira M, Candoni A, Verga L, Busca A, Delia M, Nosari A, Caramatti C, Castagnola C, Cattaneo C, Fanci R, Chierichini A, Melillo L, Mitra ME, Picardi M, Potenza L, Salutari P, Vianelli N, Facchini L, Cesarini M, De Paolis MR, Di Blasi R, Farina F, Venditti A, Ferrari A, Garzia M, Gasbarrino C, Invernizzi R, Lessi F, Manna A, Martino B, Nadali G, Offidani M, Paris L, Pavone V, Rossi G, Spadea A, Specchia G, Trecarichi EM, Vacca A, Cesaro S, Perriello V, Aversa F, Tumbarello M, Pagano L; SEIFEM Group (Sorveglianza Epidemiologica Infezioni Fungine in Emopatie Maligne). Pre-chemotherapy risk factors for invasive fungal diseases: prospective analysis of 1,192 patients with newly diagnosed acute myeloid leukemia (SEIFEM 2010-a multicenter study). Haematologica. 2015 Feb;100(2):284-92. doi: 10.3324/haematol.2014.113399.
- Derived from this study: PubMed 24948702Pagano L, Verga L, Busca A, Martino B, Mitra ME, Fanci R, Ballanti S, Picardi M, Castagnola C, Cattaneo C, Nadali G, Nosari A, Candoni A, Caira M, Salutari P, Lessi F, Aversa F, Tumbarello M. Systemic antifungal treatment after posaconazole prophylaxis: results from the SEIFEM 2010-C survey. J Antimicrob Chemother. 2014 Nov;69(11):3142-7. doi: 10.1093/jac/dku227. Epub 2014 Jun 19.
- Derived from this study: PubMed 22955439Pagano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia and Aspergillosis, run by Catholic University of the Sacred Heart at 42 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Invasive fungal infections (time frame: 30th day after the end of first line chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01315925, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2011.