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

Condition(s) targeted: Antifungal Prophylaxis

Intervention: Itraconazole (Drug); Vfend - voriconazole (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

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)

Study design: Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Success at Day 180: Survival at day 180; No breakthrough invasive fungal infection; No discontinuation of study medication for greater than 14 days

Secondary outcome:

Success at day 100; Time to breakthrough IFI;

Survival at day 180;

Safety and Tolerability of two treatments; Durations of study treatments; Use of other systemic antifungal agents

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Bmo 625 00, Czech Republic; Recruiting

Pfizer Investigational Site, Praha 128 20, Czech Republic; Active, not recruiting

Pfizer Investigational Site, cairo, Egypt; Active, not recruiting

Pfizer Investigational Site, Creteil 94010, France; Completed

Pfizer Investigational Site, Paris 75475, France; Completed

Pfizer Investigational Site, Caen 14033, France; Completed

Pfizer Investigational Site, Pessac 33600, France; Completed

Pfizer Investigational Site, Rouen Cedex 76038, France; Completed

Pfizer Investigational Site, VILLEJUIF 94805, France; Completed

Pfizer Investigational Site, Vandoeuvre Les Nancy Cedex 54511, France; Completed

Pfizer Investigational Site, Athens 11527, Greece; Active, not recruiting

Pfizer Investigational Site, Amman, Jordan; Active, not recruiting

Pfizer Investigational Site, Porto 4200-072, Portugal; Recruiting

Pfizer Investigational Site, Lisboa 1099-023, Portugal; Active, not recruiting

Pfizer Investigational Site, St. Petersburg 197089, Russian Federation; Recruiting

Pfizer Investigational Site, Moscow 117997, Russian Federation; Active, not recruiting

Pfizer Investigational Site, BARCELONA 08025, Spain; Completed

Pfizer Investigational Site, BARCELONA 08036, Spain; Completed

Pfizer Investigational Site, MADRID 28034, Spain; Completed

Pfizer Investigational Site, MADRID 28006, Spain; Active, not recruiting

Pfizer Investigational Site, MADRID 28041, Spain; Completed

Pfizer Investigational Site, SALAMANCA 37007, Spain; Completed

Pfizer Investigational Site, SEVILLA 41013, Spain; Completed

Pfizer Investigational Site, VALENCIA 46009, Spain; Completed

Pfizer Investigational Site, VALENCIA 46010, Spain; Completed

Pfizer Investigational Site, CH-4031 Basel, Switzerland; Active, not recruiting

Pfizer Investigational Site, GENEVE CH-1211, Switzerland; Active, not recruiting

Pfizer Investigational Site, Ankara 06590, Turkey; Active, not recruiting

Pfizer Investigational Site, Kayseri 38039, Turkey; Active, not recruiting

Pfizer Investigational Site, Glasgow G12 0YN, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Glasgow G4 0SF, United Kingdom; Active, not recruiting

Pfizer Investigational Site, London SE5 9RS, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Cambridge CB2 2QQ, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Leeds LS9-7TF, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Manchester M20 4BX, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Leicester LW1 5WW, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Bristol BS2 8BL, United Kingdom; Recruiting

Pfizer Investigational Site, Cardiff CF14 4XW, United Kingdom; Recruiting

Pfizer Investigational Site, London Nw3 2qg, United Kingdom; Completed

Pfizer Investigational Site, London SE1 9RT, United Kingdom; Active, not recruiting

Pfizer Investigational Site, BADALONA, BARCELONA 08916, Spain; Completed

Pfizer Investigational Site, Vancouver, British Columbia V5Z 1M9, Canada; Active, not recruiting

Pfizer Investigational Site, Marseille, CEDEX 09 13273, France; Completed

Pfizer Investigational Site, Winnipeg, Manitoba R3A 1R9, Canada; Active, not recruiting

Pfizer Investigational Site, Winnipeg, Manitoba R3E 0V9, Canada; Active, not recruiting

Pfizer Investigational Site, Hamilton, Ontario L8N 3Z5, Canada; Active, not recruiting

Pfizer Investigational Site, Montreal, Quebec H1T 2M4, Canada; Active, not recruiting

Pfizer Investigational Site, Sutton, Surrey SM2 5PT, United Kingdom; Completed

Pfizer Investigational Site, Exohi Asvestohoriou, Thessaloniki 57010, Greece; Active, not recruiting

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

Starting date: March 2006
Ending date: June 2009
Last updated: February 9, 2009