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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00289991

Purpose

Study is to compare antifungal prophylaxis of Voriconazole and Itraconazole in subjects who have has a Stem Cell Transplant. The success of the end point will be measures using evidence of Infection, drug compliance and survival.

Condition	Intervention	Phase
Antifungal Prophylaxis	Drug: Itraconazole Drug: Vfend - voriconazole	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prospective, Open-Label, Comparative, Multi-Center Study Of Voriconazole Compared To Itraconazole For The Primary Prophylaxis Of Invasive Fungal Infection (IFI) With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)

Resource links provided by NLM:

MedlinePlus related topics: Fungal Infections Molds

Drug Information available for: Itraconazole Voriconazole

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Success at Day 180: Survival at day 180; No breakthrough invasive fungal infection; No discontinuation of study medication for greater than 14 days [ Time Frame: 180 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Success at day 100; Time to breakthrough IFI; [ Time Frame: day 100 ] [ Designated as safety issue: No ]
Survival at day 180; [ Time Frame: day 180 ] [ Designated as safety issue: No ]
Safety and Tolerability of two treatments; Durations of study treatments; Use of other systemic antifungal agents [ Time Frame: ongoing ] [ Designated as safety issue: No ]

Enrollment:	494
Study Start Date:	March 2006
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Itraconazole: Active Comparator	Drug: Itraconazole Prophylaxis
Voriconazole: Experimental	Drug: Vfend - voriconazole Prophylaxis

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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' (Asicioglu et al 2002)
Previous history of zygomycosis
Anticipated survival less than one month

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289991

Show 49 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A1501073
Study First Received:	February 9, 2006
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00289991 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Anti-Infective Agents
Mycoses
Antiparasitic Agents
Antiprotozoal Agents
Therapeutic Uses

Antifungal Agents
Voriconazole
Hydroxyitraconazole
Itraconazole
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010