Study is to compare antifungal prophylaxis of Voriconazole and Itraconazole in subjects who have had a Stem Cell Transplant. The success of the end point will be measured using evidence of Infection, drug compliance and survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
489
Prophylaxis
Prophylaxis
Success at Day 180: Percent of Responders (Randomization Strata)
Percent of responders (by randomization strata) with success of antifungal prophylaxis at 180 days after allogeneic hematopoietic stem cell transplant (HSCT). Success: alive at Day 180 (Visit 9), had not developed a breakthrough proven or probable invasive fungal infection (IFI) by Visit 9, and received full course of study drug prophylaxis without interruption of greater than 14 days in total during the prophylaxis period; defined as failure if these criteria were not met. Additionally, if subject withdrew from study completely before Visit 9, imputed as failure at Visit 9 (programmatically).
Time frame: Day 180 (Visit 9)
Success at Day 100: Percent of Responders (Randomization Strata)
Percent of responders (by randomization strata) with success of antifungal prophylaxis at 100 days after allogeneic HSCT. Success defined as: alive at Day 100 (Visit 7), had not developed a breakthrough proven or probable IFI by Visit 7, and received full course of study drug prophylaxis without an interruption of \>14 days in total during the prophylaxis period; defined as failure if these criteria were not met. Additionally, if subject withdrew from study completely before Visit 7, imputed as failure at Visit 7 (programmatically).
Time frame: Day 100 (Visit 7)
Time to Breakthrough Invasive Fungal Infection (IFI)
Summary of time (in days) from start of prophylaxis to first recorded occurrence of breakthrough proven or probable IFI.
Time frame: Day 1 up to Day 180 (Visit 9)
Percent of Subjects With Occurrence of Breakthrough IFI
Percent of subjects with occurrence of breakthrough IFI (proven or probable). Included all subjects in the MITT population.
Time frame: Day 1 up to Day 100 (Visit 7) and Day 180 (Visit 9)
Survival: Percent of Subjects Who Died at or Before Day 180
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Pfizer Investigational Site
Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
Pfizer Investigational Site
Winnipeg, Manitoba, Canada
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Hamilton, Ontario, Canada
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Montreal, Quebec, Canada
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Bmo, Czechia
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Prague, Czechia
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Cairo, Egypt
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Marseille, Cedex 09, France
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Caen, France
...and 39 more locations
Percent of subjects who died at or before Day 180, derived from the crude death rate. All subjects in the MITT population included in this proportion.
Time frame: Day 1 up to Day 180 (Visit 9)
Time to Discontinuation of Study Treatment
Time in days to discontinuation of study treatment defined as the number of days from first dose to last dose inclusive as recorded in the dosing log.
Time frame: Day 1 up to Day 180 (Visit 9)
Survival: Percent of Subjects Who Died Within 1 Year
Percent of subjects who died within 1 year after transplant, derived from the crude death rate. All subjects in the MITT population included in this proportion. Only deaths up until and including 365 days after first dose of study medication included in the analysis.
Time frame: Day 1 up to 1 year (Day 365)
Duration of Treatment
Median duration in days of treatment. Treatment is defined as the total number of days on which subjects took medication.
Time frame: Day 1 up to Day 180
Percent of Subjects With Use of Other Systemic Antifungal Agents as Empirical or Therapeutic Treatment
Percent of subjects who used other systemic antifungal agents as empirical or therapeutic treatment, defined as either empirical: subject took a systemic antifungal agent at any time after the day of first dose of medication and did not develop a breakthrough proven or probable IFI during the study or therapeutic: subject developed a breakthrough proven or probable IFI.
Time frame: Day 1 up to Day 180