Status:
COMPLETED
Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)
Lead Sponsor:
Pfizer
Conditions:
Antifungal Prophylaxis of Invasive Fungal Infections
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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, ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
489 Patients enrolled
Trial Details
Trial ID
NCT00289991
Start Date
March 1 2006
End Date
February 1 2009
Last Update
November 20 2015
Active Locations (49)
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1
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
2
Pfizer Investigational Site
Winnipeg, Manitoba, Canada, R3A 1R9
3
Pfizer Investigational Site
Winnipeg, Manitoba, Canada, R3E 0V9
4
Pfizer Investigational Site
Hamilton, Ontario, Canada, L8N 3Z5