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

Completed

• Conditions: Mycoses; Leukemia
• Interventions: Other: Standard Care

• Registration Number: NCT01254318
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-05
• Study First Submitted QC: 2010-12-03
• Study First Posted: 2010-12-06
• Study Start: 2013-03
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2016-09
• Results First Submitted: 2016-09-13
• Results First Submitted QC: 2016-09-13
• Last Update Submitted: 2016-09-13
• Results First Posted: 2016-11-02
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants at high risk for IFI	Standard Care	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Non-Candida Invasive Fungal Infections at a Single Institution	365 days	Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With a Specific Fungal Pathogen at a Single Institution	365 days	Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of participants with a specific fungal pathogen.
Percentage of Participants With Invasive Fungal Infections in Canada	365 days	Data were to be extracted from participant hospital records from 5-9 centers across Canada starting from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.