Assessment of the Fungal Infection Incidence Across Canada for High Risk Participants With Hematological Disease (P07501) (TRAFIC)

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Mycoses; Leukemia

Treatments: Other: Standard Care

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01254318

P07501

MK-5592-071 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

130 participants in 1 patient group

Participants at high risk for IFI

Description:

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.

Treatment:

Other: Standard Care