Assessment of the Fungal Infection Incidence Across Canada for High Risk Subjects With Hematological Disease (Study P07501 AM1) (TRAFIC)
This will be a retrospective study that includes retrospective chart reviews at major institutions across Canada. The intent of the study is to generate both regional and national incidence data for non-Candida invasive fungal infections (IFI) in high risk subjects. The study will include participants receiving stem cell transplant and high dose chemotherapy treatment for leukemia.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Temporal Realistic Assessment of the Fungal Infection Incidence Across Canada for High Risk Subjects With Hematological Disease (TRAFIC)|
- Incidence of non-Candida invasive fungal infections at each center [ Time Frame: 365 days ] [ Designated as safety issue: No ]Determination of the incidence of non-Candida invasive fungal infections in high-risk participants across institutions in Canada
- Incidence of specific fungal pathogen in each institution [ Time Frame: 365 days ] [ Designated as safety issue: No ]
- Overall incidence of invasive fungal infections in Canada [ Time Frame: 365 days ] [ Designated as safety issue: No ]
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Participants at high risk for IFI
Participants will be considered high-risk if they are undergoing high-dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants are also considered to be at high risk for IFI if they have undergone allogeneic hematopoietic stem-cell transplantation.
Other: Standard Care
Health-care interventions will be recorded, no additional procedures outside the standard of care will be required.