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

NCT ID: NCT00289991

Last Updated: 2015-11-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

489 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2009-02-28

Brief Summary

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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

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Conditions

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Antifungal Prophylaxis of Invasive Fungal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Itraconazole

Group Type ACTIVE_COMPARATOR

Itraconazole

Intervention Type DRUG

Prophylaxis

Voriconazole

Group Type EXPERIMENTAL

Vfend - voriconazole

Intervention Type DRUG

Prophylaxis

Interventions

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Itraconazole

Prophylaxis

Intervention Type DRUG

Vfend - voriconazole

Prophylaxis

Intervention Type DRUG

Other Intervention Names

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Vfend

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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Hamilton, Ontario, Canada

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Montreal, Quebec, Canada

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Bmo, , Czechia

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Prague, , Czechia

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Cairo, , Egypt

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Marseille, Cedex 09, France

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Caen, , France

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Créteil, , France

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Paris, , France

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Pessac, , France

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Rouen, , France

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Vandœuvre-lès-Nancy, , France

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Villejuif, , France

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Exohi Asvestohoriou, Thessaloniki, Greece

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Athens, , Greece

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Amman, , Jordan

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Lisbon, , Portugal

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Porto, , Portugal

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Moscow, , Russia

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Saint Petersburg, , Russia

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Badalona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Salamanca, Salamanca, Spain

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Seville, Sevilla, Spain

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Valencia, Valencia, Spain

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Valencia, Valencia, Spain

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Ch-4031 Basel, , Switzerland

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Geneva, , Switzerland

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Ankara, , Turkey (Türkiye)

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Kayseri, , Turkey (Türkiye)

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Sutton, Surrey, United Kingdom

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Bristol, , United Kingdom

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Cambridge, , United Kingdom

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Cardiff, , United Kingdom

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Glasgow, , United Kingdom

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Glasgow, , United Kingdom

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Leeds, , United Kingdom

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Leicester, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Countries

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Canada Czechia Egypt France Greece Jordan Portugal Russia Spain Switzerland Turkey (Türkiye) United Kingdom

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1501073

To obtain contact information for a study center near you, click here.

Other Identifiers

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A1501073

Identifier Type: -

Identifier Source: org_study_id