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

This study has been completed.
Sponsor:
Collaborator:
European Group for Blood and Marrow Transplantation
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00143312
First received: August 31, 2005
Last updated: September 23, 2009
Last verified: September 2009
  Purpose

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


Condition Intervention Phase
Prophylaxis Of Invasive Fungal Infections
Drug: voriconazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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).

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit [ Time Frame: 150 days ] [ Designated as safety issue: No ]
  • Time to Occurrence of Proven or Probable Invasive Fungal Infection (IFI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Time to Occurrence of Proven or Probable New (New Pathogen) Invasive Fungal Infection (IFI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Time to Occurrence of Proven or Probable Recurrent Invasive Fungal Infection (IFI) (Same Pathogen as Previous Baseline IFI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Survival Without Proven or Probable Invasive Fungal Infection (IFI) [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: February 2005
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: voriconazole
Voriconazole is given to patients at least 48 hours after chemotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143312

Locations
Belgium
Pfizer Investigational Site
Leuven, Belgium, 3000
France
Pfizer Investigational Site
Marseille, Cedex 09, France, 13273
Pfizer Investigational Site
Creteil, France, 94010
Pfizer Investigational Site
Nantes, France, 44035 cedex
Pfizer Investigational Site
Pessac, France, 33600
Pfizer Investigational Site
Strasbourg, France, 67098
Germany
Pfizer Investigational Site
Koeln, Germany, 50937
Pfizer Investigational Site
Mainz, Germany, 55101
Pfizer Investigational Site
Wuerzburg, Germany, 97070
Portugal
Pfizer Investigational Site
Lisboa, Portugal, 1099-023
Spain
Pfizer Investigational Site
Barcelona, Spain, 08036
Pfizer Investigational Site
Barcelona, Spain, 08025
Pfizer Investigational Site
Madrid, Spain, 28006
Sweden
Pfizer Investigational Site
Stockholm, Sweden, 141 86
Switzerland
Pfizer Investigational Site
CH-4031 Basel, Switzerland
United Kingdom
Pfizer Investigational Site
London, United Kingdom, W12 0NN
Pfizer Investigational Site
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Pfizer
European Group for Blood and Marrow Transplantation
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00143312     History of Changes
Other Study ID Numbers: A1501038
Study First Received: August 31, 2005
Results First Received: April 2, 2009
Last Updated: September 23, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Pfizer:
Invasive Fungal Infection, Allogenic Stem Cell Transplant, prophylaxis, leukemia, voriconazole

Additional relevant MeSH terms:
Communicable Diseases
Infection
Mycoses
Voriconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014