Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)
- Conditions
- Antifungal Prophylaxis of Invasive Fungal Infections
- Interventions
- Registration Number
- NCT00289991
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 489
- Allogeneic HSCT for acute leukemia (AML, ALL or myelodysplastic syndrome) failed lymphoma therapy or transformation of CML
- Male and Female over 12 years or greater
- Possible, probable or proven IFI at study entry or at any time in 6 months prior to study entry, defined according to the 'consensus criteria' (Ascioglu et al 2002)
- Previous history of zygomycosis
- Anticipated survival less than one month
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Voriconazole Vfend - voriconazole - Itraconazole Itraconazole -
- Primary Outcome Measures
Name Time Method Success at Day 180: Percent of Responders (Randomization Strata) Day 180 (Visit 9) 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).
- Secondary Outcome Measures
Name Time Method Success at Day 100: Percent of Responders (Randomization Strata) Day 100 (Visit 7) 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 to Breakthrough Invasive Fungal Infection (IFI) Day 1 up to Day 180 (Visit 9) Summary of time (in days) from start of prophylaxis to first recorded occurrence of breakthrough proven or probable IFI.
Percent of Subjects With Occurrence of Breakthrough IFI Day 1 up to Day 100 (Visit 7) and Day 180 (Visit 9) Percent of subjects with occurrence of breakthrough IFI (proven or probable). Included all subjects in the MITT population.
Survival: Percent of Subjects Who Died at or Before Day 180 Day 1 up to Day 180 (Visit 9) 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 to Discontinuation of Study Treatment Day 1 up to Day 180 (Visit 9) 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.
Survival: Percent of Subjects Who Died Within 1 Year Day 1 up to 1 year (Day 365) 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.
Duration of Treatment Day 1 up to Day 180 Median duration in days of treatment. Treatment is defined as the total number of days on which subjects took medication.
Percent of Subjects With Use of Other Systemic Antifungal Agents as Empirical or Therapeutic Treatment Day 1 up to Day 180 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.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇧Manchester, United Kingdom