SEIFEM 2015: Fungemia in Hematologic Malignancies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Rate of fungemia outbreak during antifungal prophylaxis
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- — to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients diagnosed with hematologic malignancies and eligible to chemotherapy
Exclusion Criteria
- •Patients not eligible to chemotherapy
Outcomes
Primary Outcomes
Rate of fungemia outbreak during antifungal prophylaxis
Time Frame: Since 30 days average before fungemia onset
Secondary Outcomes
- Mortality from fungemia(After 30 days from fungemia onset)
Investigators
LIVIO PAGANO
MD, Hematology Professor
Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne