Clinical trial NCT00289991: Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Antifungal Prophylaxis of Invasive Fungal Infections
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-02-10
Enrollment: 489
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Success at Day 180: Percent of Responders (Randomization Strata)
timeFrame: Day 180 (Visit 9)
Secondary outcomes:
measure: Success at Day 100: Percent of Responders (Randomization Strata)
timeFrame: Day 100 (Visit 7)
measure: Time to Breakthrough Invasive Fungal Infection (IFI)
timeFrame: Day 1 up to Day 180 (Visit 9)
measure: Percent of Subjects With Occurrence of Breakthrough IFI
timeFrame: Day 1 up to Day 100 (Visit 7) and Day 180 (Visit 9)
measure: Survival: Percent of Subjects Who Died at or Before Day 180
timeFrame: Day 1 up to Day 180 (Visit 9)
measure: Time to Discontinuation of Study Treatment
timeFrame: Day 1 up to Day 180 (Visit 9)
measure: Survival: Percent of Subjects Who Died Within 1 Year
timeFrame: Day 1 up to 1 year (Day 365)
measure: Duration of Treatment
timeFrame: Day 1 up to Day 180
measure: Percent of Subjects With Use of Other Systemic Antifungal Agents as Empirical or Therapeutic Treatment
timeFrame: Day 1 up to Day 180
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Bmo
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha
country: Czech Republic
facility: Pfizer Investigational Site
city: Cairo
country: Egypt
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
state: Cedex 09
city: Caen
country: France
facility: Pfizer Investigational Site
city: Creteil
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Pessac
country: France
facility: Pfizer Investigational Site
city: Rouen Cedex
country: France
facility: Pfizer Investigational Site
city: Vandoeuvre Les Nancy Cedex
country: France
facility: Pfizer Investigational Site
city: Villejuif
country: France
facility: Pfizer Investigational Site
city: Exohi Asvestohoriou
country: Greece
facility: Pfizer Investigational Site
state: Thessaloniki
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Amman
country: Jordan
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Badalona
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Salamanca
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: CH-4031 Basel
country: Switzerland
facility: Pfizer Investigational Site
city: Geneve
country: Switzerland
facility: Pfizer Investigational Site
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Kayseri
country: Turkey
facility: Pfizer Investigational Site
city: Sutton
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: Bristol
country: United Kingdom
facility: Pfizer Investigational Site
city: Cambridge
country: United Kingdom
facility: Pfizer Investigational Site
city: Cardiff
country: United Kingdom
facility: Pfizer Investigational Site
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Leeds
country: United Kingdom
facility: Pfizer Investigational Site
city: Leicester
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: