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

• Sponsor: Merck Sharp & Dohme LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01254318
• Collaborator: McGill University Health Centre/Research Institute of the McGill University Health Centre (Other)
• Enrollment: 130
• Duration (Months): 20

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mycoses; Leukemia	Other: Standard Care

Study Design

• Study Type: Observational
• Actual Enrollment: 130 participants
• 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)
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

• Study Director: Medical Director, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT01254318
• Other Study ID Numbers: P07501; MK-5592-071
• First Posted: Dec 6, 2010
• Last Update Posted: Nov 2, 2016
• Last Verified: Sep 1, 2016

• Keywords provided by Merck Sharp & Dohme LLC: hematological malignancy; fungal infection; leukemia
• Additional relevant MeSH terms: Infections; Mycoses; Hematologic Diseases

Study Results

Participant Flow

Recruitment Details	Participants with hematologic malignancy requiring high dose chemotherapy with or without stem cell transplant were selected from a single tertiary care center in Canada.

Arm/Group Title	Participants at High Risk for IFI
Arm/Group Description	Participants were considered high risk for IFI if they were 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 were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
Period Title: Overall Study
STARTED	130
COMPLETED	78
NOT COMPLETED	52

Baseline Characteristics

Arm/Group Title	Participants at High Risk for IFI
Arm/Group Description	Participants were considered high risk for IFI if they were 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 were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem-cell transplantation.
Overall Participants	130
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	55.28 (15.26)
Sex: Female, Male (Count of Participants)
Female	51 39.2%
Male	79 60.8%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Non-Candida Invasive Fungal Infections at a Single Institution
Description	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.
Time Frame	365 days

Outcome Measure Data

Analysis Population Description

All enrolled participants who received stem-cell transplant and high dose chemotherapy for leukemia.

Arm/Group Title	Participants at High Risk for IFI
Arm/Group Description	Participants were considered high risk for IFI if they were 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 were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
Measure Participants	130
Number (95% Confidence Interval) [Percentage of participants]	32.3 24.8%

2. Secondary Outcome

Title	Percentage of Participants With a Specific Fungal Pathogen at a Single Institution
Description	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.
Time Frame	365 days

Outcome Measure Data

Analysis Population Description

All enrolled participants who received stem cell transplant and high dose chemotherapy for leukemia.

Arm/Group Title	Participants at High Risk for IFI
Arm/Group Description	Participants were considered high risk for IFI if they were 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 were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
Measure Participants	130
Aspergillus	8.5 6.5%
Fusarium	1.5 1.2%
Penicillium	0.8 0.6%
Missing	21.5 16.5%

3. Secondary Outcome

Title	Percentage of Participants With Invasive Fungal Infections in Canada
Description	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.
Time Frame	365 days

Outcome Measure Data

Analysis Population Description

Whereas enrollment at 5-9 centers in Canada was planned, this was not accomplished, as data were only collected from a single institution in Canada.

Arm/Group Title	Participants at High Risk for IFI
Arm/Group Description	Participants were considered high risk for IFI if they were 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 were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
Measure Participants	0

Adverse Events

Adverse Event Reporting Description	Adverse Events were not collected during this study.
Arm/Group Title	Participants at High Risk for IFI
Arm/Group Description	Participants were considered high risk for IFI if they were 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 were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
All Cause Mortality
	Participants at High Risk for IFI
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Participants at High Risk for IFI
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Participants at High Risk for IFI
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Principal Investigator and Institution agree to provide 45 days written notice to Sponsor prior to submission for publication or presentation to permit Sponsor to review drafts of abstracts and manuscripts for publication which report any results arising out of the Study.