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

September 23, 2009 updated by: Pfizer

Prospective, Open-Label, Non-Comparative, Multicenter Study for the Secondary Prophylaxis of Invasive Fungal Infections (IFI) With Voriconazole in Patients With Allogeneic Stem Cell Transplants (SCT).

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Pfizer Investigational Site
  • France
      • Creteil, France, 94010
        • Pfizer Investigational Site
      • Nantes, France, 44035 cedex
        • Pfizer Investigational Site
      • Pessac, France, 33600
        • Pfizer Investigational Site
      • Strasbourg, France, 67098
        • Pfizer Investigational Site
    • Cedex 09
      • Marseille, Cedex 09, France, 13273
        • Pfizer Investigational Site
  • Germany
      • Koeln, Germany, 50937
        • Pfizer Investigational Site
      • Mainz, Germany, 55101
        • Pfizer Investigational Site
      • Wuerzburg, Germany, 97070
        • Pfizer Investigational Site
  • Portugal
      • Lisboa, Portugal, 1099-023
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • Pfizer Investigational Site
      • Barcelona, Spain, 08025
        • Pfizer Investigational Site
      • Madrid, Spain, 28006
        • Pfizer Investigational Site
  • Sweden
      • Stockholm, Sweden, 141 86
        • Pfizer Investigational Site
  • Switzerland
      • CH-4031 Basel, Switzerland
        • Pfizer Investigational Site
  • United Kingdom
      • London, United Kingdom, W12 0NN
        • Pfizer Investigational Site
      • Manchester, United Kingdom, M20 4BX
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: voriconazole
Voriconazole is given to patients at least 48 hours after chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit
Time Frame: 12 months
Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 12-month follow up
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit
Time Frame: 6 months
Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 6-month follow up
6 months
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit
Time Frame: 150 days
Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until the End of Prophylaxis visit
150 days
Time to Occurrence of Proven or Probable Invasive Fungal Infection (IFI)
Time Frame: 12 months
Time to occurrence of proven or probable IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI since the exact day on which the IFI began will not be known.
12 months
Time to Occurrence of Proven or Probable New (New Pathogen) Invasive Fungal Infection (IFI)
Time Frame: 12 months
Time to occurrence of proven or probable new (new pathogen) IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI.
12 months
Time to Occurrence of Proven or Probable Recurrent Invasive Fungal Infection (IFI) (Same Pathogen as Previous Baseline IFI)
Time Frame: 12 months
Time to occurrence of proven or probable recurrent (same pathogen as baseline) IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI. The pathogen identified as the positive culture recorded nearest to, but not after, the proven or probable IFI, was assumed to be responsible for the IFI.
12 months
Survival Without Proven or Probable Invasive Fungal Infection (IFI)
Time Frame: 6 months, 12 months
Number of participants who survive (ie., are alive) without proven or probable IFI at each of the 6 and 12 month follow-up visits
6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

European Society for Blood and Marrow Transplantation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

August 31, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Estimate)

October 6, 2009

Last Update Submitted That Met QC Criteria

September 23, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1501038

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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