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

Primary Purpose

Prophylaxis Of Invasive Fungal Infections

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
voriconazole
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prophylaxis Of Invasive Fungal Infections focused on measuring Invasive Fungal Infection, Allogenic Stem Cell Transplant, prophylaxis, leukemia, voriconazole

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit
Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 6-month follow up
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit
Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until the End of Prophylaxis visit
Time to Occurrence of Proven or Probable Invasive Fungal Infection (IFI)
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.
Time to Occurrence of Proven or Probable New (New Pathogen) Invasive Fungal Infection (IFI)
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.
Time to Occurrence of Proven or Probable Recurrent Invasive Fungal Infection (IFI) (Same Pathogen as Previous Baseline IFI)
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.
Survival Without Proven or Probable Invasive Fungal Infection (IFI)
Number of participants who survive (ie., are alive) without proven or probable IFI at each of the 6 and 12 month follow-up visits

Full Information

First Posted
August 31, 2005
Last Updated
September 23, 2009
Sponsor
Pfizer
Collaborators
European Society for Blood and Marrow Transplantation
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1. Study Identification

Unique Protocol Identification Number
NCT00143312
Brief Title
Voriconazole for Secondary Prophylaxis of Invasive Fungal Infections in Patients With Allogeneic Stem Cell Transplants
Acronym
VOSIFI
Official Title
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).
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer
Collaborators
European Society for Blood and Marrow Transplantation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prophylaxis Of Invasive Fungal Infections
Keywords
Invasive Fungal Infection, Allogenic Stem Cell Transplant, prophylaxis, leukemia, voriconazole

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
voriconazole
Intervention Description
Voriconazole is given to patients at least 48 hours after chemotherapy
Primary Outcome Measure Information:
Title
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit
Description
Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 12-month follow up
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit
Description
Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 6-month follow up
Time Frame
6 months
Title
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit
Description
Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until the End of Prophylaxis visit
Time Frame
150 days
Title
Time to Occurrence of Proven or Probable Invasive Fungal Infection (IFI)
Description
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.
Time Frame
12 months
Title
Time to Occurrence of Proven or Probable New (New Pathogen) Invasive Fungal Infection (IFI)
Description
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.
Time Frame
12 months
Title
Time to Occurrence of Proven or Probable Recurrent Invasive Fungal Infection (IFI) (Same Pathogen as Previous Baseline IFI)
Description
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.
Time Frame
12 months
Title
Survival Without Proven or Probable Invasive Fungal Infection (IFI)
Description
Number of participants who survive (ie., are alive) without proven or probable IFI at each of the 6 and 12 month follow-up visits
Time Frame
6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Marseille
State/Province
Cedex 09
ZIP/Postal Code
13273
Country
France
Facility Name
Pfizer Investigational Site
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Pfizer Investigational Site
City
Nantes
ZIP/Postal Code
44035 cedex
Country
France
Facility Name
Pfizer Investigational Site
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
Pfizer Investigational Site
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Pfizer Investigational Site
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Pfizer Investigational Site
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Facility Name
Pfizer Investigational Site
City
Wuerzburg
ZIP/Postal Code
97070
Country
Germany
Facility Name
Pfizer Investigational Site
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Pfizer Investigational Site
City
CH-4031 Basel
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1501038&StudyName=Voriconazole%20for%20Secondary%20Prophylaxis%20of%20Invasive%20Fungal%20Infections%20in%20Patients%20with%20Allogeneic%20Stem%20Cell%20Transplants
Description
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Voriconazole for Secondary Prophylaxis of Invasive Fungal Infections in Patients With Allogeneic Stem Cell Transplants

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