Fungemia in Hematologic Malignancies
- Conditions
- Multiple MyelomaChronic LeukemiaAcute LeukemiaLymphoma
- Registration Number
- NCT02451592
- Lead Sponsor
- Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- Patients diagnosed with hematologic malignancies and eligible to chemotherapy
- Patients not eligible to chemotherapy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of fungemia outbreak during antifungal prophylaxis Since 30 days average before fungemia onset
- Secondary Outcome Measures
Name Time Method Mortality from fungemia After 30 days from fungemia onset
Trial Locations
- Locations (1)
Catholic University of Sacred Heart
🇮🇹Rome, Italy