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

NCT01254318 | Completed Results

• 2 other identifiers: P07501MK-5592-071
• Study Type: observational
• Target: 130
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mycoses; Leukemia

Keywords

hematological malignancy; fungal infection; leukemia

Outcome Measures

Primary Outcomes (1)

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

  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.

  365 days

Secondary Outcomes (2)

• Percentage of Participants With a Specific Fungal Pathogen at a Single Institution

  365 days

• Percentage of Participants With Invasive Fungal Infections in Canada

  365 days

Study Arms (1)

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

Interventions

Standard Care OTHER

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

Participants at high risk for IFI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants at high risk for IFI at medical institutions in Canada

You may qualify if:

• A hematological malignancy requiring high dose chemotherapy with or without bone marrow transplant

You may not qualify if:

• Their IFI is not related to hematological malignancies.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

MeSH Terms

Conditions

Mycoses; Leukemia; Hematologic Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: December 6, 2010
• Study Start: March 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 2, 2016
• Results First Posted: November 2, 2016

Record last verified: 2016-09