ClinicalTrials.gg
CompletedNCT02451592Updated Oct 20, 2016

Fungemia in Hematologic Malignancies

An observational study in Acute Leukemia, Chronic Leukemia and Multiple Myeloma, sponsored by Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne. Completed at 1 site in Italy. Open to participants aged Up to 80 Years. Per ClinicalTrials.gov, last updated 2016-10-20.

Sponsored by Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
300
Ages
Up to 80 Years
Sex
All
01

Study summary

The purpose of this study is to determine the risk factors for fungemia in a population of patients diagnosed with hematologic malignancies and eligible for chemotherapy.

Read the detailed description

The coordinating center provides all participating centers with an epidemiologic form, in order to collect data in a comparable way. The requested informations include type of malignancy and its treatment, environmental expositions, laboratory work up, antifungal prophylaxis, clinical signs of infection, microbiological findings, antifungal therapy and outcome of infection at 30 days.

The planned sample size is about 300 patients to be recruited in 35 participating center over 5 years, in a retrospective-prospective fashion. Data check will be performed at the coordinating center. Missing data will be managed to minimize incomplete reports.

Statistical analysis will be performed by an independent reviewer, in order to assess risk factors predictive of fungal infection and outcome.

02

Conditions studied

  • Acute Leukemia
  • Chronic Leukemia
  • Multiple Myeloma
  • Lymphoma

Keywords

  • Fungemia
  • Hematologic malignancies
03

In context

Multiple Myeloma

3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.

This study's enrollment of 300 is above the median of 150 across 486 observational studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Consecutive adult and pediatric patients affected by hematologic malignancies and eligible to chemotherapy that develop fungemia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients diagnosed with hematologic and eligible to chemotherapy

Exclusion criteria

Exclusion Criteria:

  • Patients not eligible to chemotherapy
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
300 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Rate of fungemia outbreak during antifungal prophylaxis

    Time frame: Since 30 days average before fungemia onset

Secondary outcomes

  1. Mortality from fungemia

    Time frame: After 30 days from fungemia onset

07

Study locations

1 site
  • Catholic University of Sacred Heart
    Rome, 00168, Italy
08

References and documents

Publications

  • Pagano L, Caira M, Candoni A, Offidani M, Fianchi L, Martino B, Pastore D, Picardi M, Bonini A, Chierichini A, Fanci R, Caramatti C, Invernizzi R, Mattei D, Mitra ME, Melillo L, Aversa F, Van Lint MT, Falcucci P, Valentini CG, Girmenia C, Nosari A. The epidemiology of fungal infections in patients with hematologic malignancies: the SEIFEM-2004 study. Haematologica. 2006 Aug;91(8):1068-75. PubMed 16885047 ↗
  • Pagano L, Caira M, Nosari A, Van Lint MT, Candoni A, Offidani M, Aloisi T, Irrera G, Bonini A, Picardi M, Caramatti C, Invernizzi R, Mattei D, Melillo L, de Waure C, Reddiconto G, Fianchi L, Valentini CG, Girmenia C, Leone G, Aversa F. Fungal infections in recipients of hematopoietic stem cell transplants: results of the SEIFEM B-2004 study--Sorveglianza Epidemiologica Infezioni Fungine Nelle Emopatie Maligne. Clin Infect Dis. 2007 Nov 1;45(9):1161-70. doi: 10.1086/522189. Epub 2007 Sep 26. PubMed 17918077 ↗
  • 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. PubMed 22955439 ↗
  • Caira 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 25638805 ↗
  • Bassetti M, Merelli M, Righi E, Diaz-Martin A, Rosello EM, Luzzati R, Parra A, Trecarichi EM, Sanguinetti M, Posteraro B, Garnacho-Montero J, Sartor A, Rello J, Tumbarello M. Epidemiology, species distribution, antifungal susceptibility, and outcome of candidemia across five sites in Italy and Spain. J Clin Microbiol. 2013 Dec;51(12):4167-72. doi: 10.1128/JCM.01998-13. Epub 2013 Oct 9. PubMed 24108614 ↗
  • Pagano L, Fianchi L, Fanci R, Candoni A, Caira M, Posteraro B, Morselli M, Valentini CG, Farina G, Mitra ME, Offidani M, Sanguinetti M, Tosti ME, Nosari A, Leone G, Viale P. Caspofungin for the treatment of candidaemia in patients with haematological malignancies. Clin Microbiol Infect. 2010 Mar;16(3):298-301. doi: 10.1111/j.1469-0691.2009.02832.x. Epub 2009 Jun 22. PubMed 19549221 ↗
  • Pagano L, Antinori A, Ammassari A, Mele L, Nosari A, Melillo L, Martino B, Sanguinetti M, Equitani F, Nobile F, Carotenuto M, Morra E, Morace G, Leone G. Retrospective study of candidemia in patients with hematological malignancies. Clinical features, risk factors and outcome of 76 episodes. Eur J Haematol. 1999 Aug;63(2):77-85. doi: 10.1111/j.1600-0609.1999.tb01120.x. PubMed 10480286 ↗
  • Moore CB, Sayers N, Mosquera J, Slaven J, Denning DW. Antifungal drug resistance in Aspergillus. J Infect. 2000 Nov;41(3):203-20. doi: 10.1053/jinf.2000.0747. No abstract available. PubMed 11120607 ↗
  • Sanglard D, Odds FC. Resistance of Candida species to antifungal agents: molecular mechanisms and clinical consequences. Lancet Infect Dis. 2002 Feb;2(2):73-85. doi: 10.1016/s1473-3099(02)00181-0. PubMed 11901654 ↗
  • Nucci M, Marr KA, Vehreschild MJ, de Souza CA, Velasco E, Cappellano P, Carlesse F, Queiroz-Telles F, Sheppard DC, Kindo A, Cesaro S, Hamerschlak N, Solza C, Heinz WJ, Schaller M, Atalla A, Arikan-Akdagli S, Bertz H, Galvao Castro C Jr, Herbrecht R, Hoenigl M, Harter G, Hermansen NE, Josting A, Pagano L, Salles MJ, Mossad SB, Ogunc D, Pasqualotto AC, Araujo V, Troke PF, Lortholary O, Cornely OA, Anaissie E. Improvement in the outcome of invasive fusariosis in the last decade. Clin Microbiol Infect. 2014 Jun;20(6):580-5. doi: 10.1111/1469-0691.12409. Epub 2013 Nov 18. PubMed 24118322 ↗
  • Girmenia C, Pagano L, Martino B, D'Antonio D, Fanci R, Specchia G, Melillo L, Buelli M, Pizzarelli G, Venditti M, Martino P; GIMEMA Infection Program. Invasive infections caused by Trichosporon species and Geotrichum capitatum in patients with hematological malignancies: a retrospective multicenter study from Italy and review of the literature. J Clin Microbiol. 2005 Apr;43(4):1818-28. doi: 10.1128/JCM.43.4.1818-1828.2005. PubMed 15815003 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2011, a primary completion of Dec 2015 and a completion of Jan 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 13, 2015
First posted
May 22, 2015
Start
Jan 2011
Primary completionActual
Dec 2015
CompletionActual
Jan 2016
Last update
Oct 20, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02451592
Lead sponsor
Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne
Responsible party
LIVIO PAGANO (MD, Hematology Professor, Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne) — Principal investigator
First posted
May 22, 2015
Start date
Jan 2011
Primary completion
Dec 2015
Completion
Jan 2016
Last update
Oct 20, 2016

Study contacts

Livio Pagano, Professor
principal investigator · Catholic University of Sacred Heart, Rome Italy

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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