N/A
N=130
Assessment of the Fungal Infection Incidence Across Canada for High Risk Participants With Hematological Disease (P07501)
Mycoses · Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT01254318 ↗Enrolled (actual)
130
Serious AEs
—
Results posted
Nov 2016
Primary outcome: Primary: Percentage of Participants With Non-Candida Invasive Fungal Infections at a Single Institution — 32.3 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Standard Care (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Non-Candida Invasive Fungal Infections at a Single Institution |
32.3 | — |
| SECONDARY Percentage of Participants With a Specific Fungal Pathogen at a Single Institution |
8.5; 1.5; 0.8; 21.5 | — |
| SECONDARY Percentage of Participants With Invasive Fungal Infections in Canada |
— | — |
Summary
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 participants. The study will include participants receiving stem cell transplant and high dose chemotherapy treatment for leukemia.
Eligibility Criteria
Inclusion Criteria
- To be eligible for study inclusion, the participant must have:
- A hematological malignancy requiring high dose chemotherapy with or without bone marrow transplant
Exclusion Criteria
- The participant is not eligible for study inclusion if:
- Their IFI is not related to hematological malignancies.
Data sourced from ClinicalTrials.gov (NCT01254318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.