Fungemia Survey in Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 304
- Locations
- 5
- Primary Endpoint
- Mortality at 2, 4, and 12 weeks after diagnosis of fungemia
Study Overview
Brief Summary
RATIONALE: Gathering information about how often fungal infections of the blood occur in patients with cancer or in patients who have undergone stem cell transplant may help doctors learn more about the disease.
PURPOSE: This natural history study is collecting information about fungal infections of the blood over time from patients with cancer or from patients who have undergone a stem cell transplant.
Detailed Description
OBJECTIVES:
- Determine the incidence of fungemia in relation to the number of admissions to the hospital in patients with solid tumor or hematologic malignancy or in patients who have undergone hematopoietic stem cell transplantation.
- Determine the fungal species distribution, prognostic factors for outcome, and crude and attributable mortality in patients also diagnosed with fungemia.
OUTLINE: This is a multicenter, nonrandomized, prospective study.
- Group A (no documented fungemia at study entry): Data regarding the number of patients with cancer or who have undergone hematopoietic stem cell transplantation, including those who develop documented fungemia, who are admitted to the hospital is collected for 2 years.
- Group B (documented fungemia at study entry): Fungal strains isolated from the initial positive blood culture are collected and undergo examination, including confirmation of species identification, susceptibility testing, and/or minimum inhibitory concentration determination. Data, including antifungal treatment, clinical and microbiological response to antifungal treatment (at 2, 4, and 12 weeks after diagnosis), and survival status, is collected for each documented fungemia episode* for up to 12 weeks after diagnosis of fungemia.
NOTE: *That occurs within a 2-year period.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Mortality at 2, 4, and 12 weeks after diagnosis of fungemia
Relative incidence of fungemia
Fungal species distribution
Survival in patients with fungemia
Secondary Outcomes
No secondary outcomes reported
