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Fungemia in Hematologic Malignancies

SEIFEM 2015: Fungemia in Hematologic Malignancies

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02451592
Enrollment
300
Registered
2015-05-22
Start date
2011-01-31
Completion date
2016-01-31
Last updated
2016-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Leukemia, Chronic Leukemia, Lymphoma, Multiple Myeloma

Keywords

Fungemia, Hematologic malignancies

Brief 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.

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.

Interventions

None listed

Sponsors

Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients diagnosed with hematologic malignancies and eligible to chemotherapy

Exclusion criteria

* Patients not eligible to chemotherapy

Design outcomes

Primary

MeasureTime frame
Rate of fungemia outbreak during antifungal prophylaxisSince 30 days average before fungemia onset

Secondary

MeasureTime frame
Mortality from fungemiaAfter 30 days from fungemia onset

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026