Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT) (IMPROVIT)

Pfizer

Status and phase: Completed; Phase 3

Conditions: Antifungal Prophylaxis of Invasive Fungal Infections

Treatments: Drug: Itraconazole; Drug: Vfend - voriconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00289991

A1501073

Details and patient eligibility

About

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.

Enrollment: 489 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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489 participants in 2 patient groups

Itraconazole

Active Comparator group

Treatment:

Drug: Itraconazole

Voriconazole

Experimental group

Treatment:

Drug: Vfend - voriconazole