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

Leukemia Clinical Trial

— TRAFIC  

Official title:

Temporal Realistic Assessment of the Fungal Infection Incidence Across Canada for High Risk Subjects With Hematological Disease (TRAFIC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254318
• Other study ID #: P07501
• Status: Completed
• Phase: N/A
• First received: November 5, 2010
• Last updated: April 9, 2015
• Start date: March 2013
• Est. completion date: November 2014

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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 subjects. The study will include participants receiving stem cell transplant and high dose chemotherapy treatment for leukemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hematologic Diseases
• Leukemia
• Mycoses

Intervention

Other:
• Standard Care
Health-care interventions will be recorded, no additional procedures outside the standard of care will be required.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	McGill University Health Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of non-Candida invasive fungal infections at each center	Determination of the incidence of non-Candida invasive fungal infections in high-risk participants across institutions in Canada	365 days	No
Secondary	Incidence of specific fungal pathogen in each institution		365 days	No
Secondary	Overall incidence of invasive fungal infections in Canada		365 days	No