Clinical Trial: Fungemia in Hematologic Malignancies

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: SEIFEM 2015: Fungemia in 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 Summary:

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.

Sponsor: Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne

Current Primary Outcome: Rate of fungemia outbreak during antifungal prophylaxis [ Time Frame: Since 30 days average before fungemia onset ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Mortality from fungemia [ Time Frame: After 30 days from fungemia onset ]

Original Secondary Outcome: Same as current

Information By: Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne

Dates:
Date Received: May 13, 2015
Date Started: January 2011
Date Completion:
Last Updated: October 19, 2016
Last Verified: October 2016