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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
McGill University Health Center
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01254318
First received: November 5, 2010
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Mycoses
Leukemia
Other: Standard Care

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Temporal Realistic Assessment of the Fungal Infection Incidence Across Canada for High Risk Subjects With Hematological Disease (TRAFIC)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Incidence of non-Candida invasive fungal infections at each center [ Time Frame: 365 days ] [ Designated as safety issue: No ]
    Determination of the incidence of non-Candida invasive fungal infections in high-risk participants across institutions in Canada


Secondary Outcome Measures:
  • Incidence of specific fungal pathogen in each institution [ Time Frame: 365 days ] [ Designated as safety issue: No ]
  • Overall incidence of invasive fungal infections in Canada [ Time Frame: 365 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: March 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Participants at high risk for IFI
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.
Other: Standard Care
Health-care interventions will be recorded, no additional procedures outside the standard of care will be required.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants at high risk for IFI at medical institutions in Canada

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01254318     History of Changes
Other Study ID Numbers: P07501
Study First Received: November 5, 2010
Last Updated: August 28, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Merck Sharp & Dohme Corp.:
hematological malignancy
fungal infection
leukemia

Additional relevant MeSH terms:
Hematologic Diseases
Infection
Leukemia
Mycoses
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 19, 2014