Voriconazole for Secondary Prophylaxis of Invasive Fungal Infections in Patients With Allogeneic Stem Cell Transplants

NCT ID: NCT00143312

Last Updated: 2009-10-06

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

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2008-04-30

Brief Summary

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To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell transplants

Detailed Description

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Conditions

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Prophylaxis Of Invasive Fungal Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

voriconazole

Intervention Type DRUG

Voriconazole is given to patients at least 48 hours after chemotherapy

Interventions

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voriconazole

Voriconazole is given to patients at least 48 hours after chemotherapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with proven or probable IFI in previous 12 months receiving an allogenic stem cell transplant for any haematological disease

Exclusion Criteria

* Pregnant or lactating women
* Severe disease other tham the underlying condition
* Active, symptomatic uncontrolled Invasive Fungal Infection
* Any evidence of active fungal disease as defined by MSG-EORTC criteria
* Concomitant use of Voriconazole 36 hours before chemotherapy until 48 hours after chemotherapy
* Other medical conditions, including HIV positive serology that would interfere with the evaluation of therapeutic response or safety of study drug
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Society for Blood and Marrow Transplantation

NETWORK

Sponsor Role collaborator

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

Leuven, , Belgium

Site Status

Pfizer Investigational Site

Marseille, Cedex 09, France

Site Status

Pfizer Investigational Site

Créteil, , France

Site Status

Pfizer Investigational Site

Nantes, , France

Site Status

Pfizer Investigational Site

Pessac, , France

Site Status

Pfizer Investigational Site

Strasbourg, , France

Site Status

Pfizer Investigational Site

Cologne, , Germany

Site Status

Pfizer Investigational Site

Mainz, , Germany

Site Status

Pfizer Investigational Site

Würzburg, , Germany

Site Status

Pfizer Investigational Site

Lisbon, Lisbon District, Portugal

Site Status

Pfizer Investigational Site

Barcelona, Barcelona, Spain

Site Status

Pfizer Investigational Site

Barcelona, Barcelona, Spain

Site Status

Pfizer Investigational Site

Madrid, Madrid, Spain

Site Status

Pfizer Investigational Site

Stockholm, , Sweden

Site Status

Pfizer Investigational Site

Ch-4031 Basel, , Switzerland

Site Status

Pfizer Investigational Site

London, , United Kingdom

Site Status

Pfizer Investigational Site

Manchester, , United Kingdom

Site Status

Countries

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Belgium France Germany Portugal Spain Sweden Switzerland United Kingdom

Related Links

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Other Identifiers

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A1501038

Identifier Type: -

Identifier Source: org_study_id

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