NCT02451592

Fungemia in Hematologic Malignancies

SEIFEM 2015: Fungemia in Hematologic Malignancies

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne · Academic / Other
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Leukemia
• Chronic Leukemia
• Multiple Myeloma
• Lymphoma

Timeline

• Start date: 2011-01-01
• Primary completion: 2015-12-01
• Completion: 2016-01-01
• First posted: 2015-05-22
• Last updated: 2016-10-20

Locations

1 site across 1 country: Italy