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Completed

NCT Number: NCT01254318

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

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.

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Key information

Conditions

Mycoses Bacterial Infections and Mycoses Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Infections Leukemia Neoplasms Neoplasms by Histologic Type Neoplasms by Site

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard care

Other

Health-care interventions will be recorded; no additional procedures outside the standard of care will be required.

Primary outcomes

  1. Percentage of Participants With Non-Candida Invasive Fungal Infections at a Single Institution

    Time frame: 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 outcomes

  1. Percentage of Participants With a Specific Fungal Pathogen at a Single Institution

    Time frame: 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.

  2. Percentage of Participants With Invasive Fungal Infections in Canada

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

Registry information

Official study title

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

Acronym: TRAFIC

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 6, 2010
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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