Trial Outcomes & Findings for Assessment of the Fungal Infection Incidence Across Canada for High Risk Participants With Hematological Disease (P07501) (NCT NCT01254318)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

130 participants

Primary outcome timeframe

365 days

Results posted on

2016-11-02

Participant Flow

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

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	130
Overall Study COMPLETED	78
Overall Study NOT COMPLETED	52

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	5
Overall Study Death	47

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants at High Risk for IFI n=130 Participants 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.
Age, Continuous	55.28 Years STANDARD_DEVIATION 15.26 • n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants
Sex: Female, Male Male	79 Participants n=5 Participants

PRIMARY outcome

Timeframe: 365 days

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

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.

Outcome measures

Outcome measures
Measure	Participants at High Risk for IFI n=130 Participants 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.
Percentage of Participants With Non-Candida Invasive Fungal Infections at a Single Institution	32.3 Percentage of participants Interval 24.4 to 41.1

SECONDARY outcome

Timeframe: 365 days

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

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.

Outcome measures

Outcome measures
Measure	Participants at High Risk for IFI n=130 Participants 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.
Percentage of Participants With a Specific Fungal Pathogen at a Single Institution Aspergillus	8.5 Percentage of participants
Percentage of Participants With a Specific Fungal Pathogen at a Single Institution Fusarium	1.5 Percentage of participants
Percentage of Participants With a Specific Fungal Pathogen at a Single Institution Penicillium	0.8 Percentage of participants
Percentage of Participants With a Specific Fungal Pathogen at a Single Institution Missing	21.5 Percentage of participants

SECONDARY outcome

Timeframe: 365 days

Population: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Participants at High Risk for IFI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER