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| ID | Type | Description | Link |
|---|---|---|---|
| MK-5592-071 | Other Identifier | Merck Protocol Number |
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| Name | Class |
|---|---|
| McGill University Health Centre/Research Institute of the McGill University Health Centre | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Care | Other | Health-care interventions will be recorded; no additional procedures outside the standard of care will be required. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Specific Fungal Pathogen 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 participants with a specific fungal pathogen. | 365 days |
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Inclusion Criteria:
Exclusion Criteria:
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Participants at high risk for IFI at medical institutions in Canada
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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Participants with hematologic malignancy requiring high dose chemotherapy with or without stem cell transplant were selected from a single tertiary care center in Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants at High Risk for IFI | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants at High Risk for IFI | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All enrolled participants who received stem-cell transplant and high dose chemotherapy for leukemia. | Posted | Number | 95% Confidence Interval | Percentage of participants | 365 days |
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Adverse Events were not collected during this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants at High Risk for IFI | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D009181 | Mycoses |
| D007938 | Leukemia |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Percentage of Participants With Invasive Fungal Infections in Canada | 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. | 365 days |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Percentage of Participants With a Specific Fungal Pathogen 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 participants with a specific fungal pathogen. | All enrolled participants who received stem cell transplant and high dose chemotherapy for leukemia. | Posted | Number | Percentage of participants | 365 days |
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|
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| Secondary | Percentage of Participants With Invasive Fungal Infections in Canada | 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. | 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. | Posted | 365 days |
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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.
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009371 | Neoplasms by Site |
| Title | Measurements |
|---|---|
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| Missing |
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