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 had a Stem Cell Transplant. The success of the end point will be measured using evidence of Infection, drug compliance and survival.

Condition	Intervention	Phase
Antifungal Prophylaxis of Invasive Fungal Infections	Drug: Itraconazole Drug: Vfend - voriconazole	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
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: Percent of Responders (Randomization Strata) [ Time Frame: Day 180 (Visit 9) ] [ Designated as safety issue: No ]
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:

Success at Day 100: Percent of Responders (Randomization Strata) [ Time Frame: Day 100 (Visit 7) ] [ Designated as safety issue: No ]
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) [ Time Frame: Day 1 up to Day 180 (Visit 9) ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 1 up to Day 100 (Visit 7) and Day 180 (Visit 9) ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 1 up to Day 180 (Visit 9) ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 1 up to Day 180 (Visit 9) ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 1 up to 1 year (Day 365) ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 1 up to Day 180 ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 1 up to Day 180 ] [ Designated as safety issue: No ]
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.

Enrollment:	489
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
Active Comparator: Itraconazole	Drug: Itraconazole Prophylaxis
Experimental: Voriconazole	Drug: Vfend - voriconazole Prophylaxis Other Name: Vfend

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' (Ascioglu 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:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00289991 History of Changes
Other Study ID Numbers:	A1501073
Study First Received:	February 9, 2006
Results First Received:	February 9, 2010
Last Updated:	March 26, 2010
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Mycoses
Itraconazole
Voriconazole
Hydroxyitraconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012