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

August 31, 2005
September 23, 2009
February 2005
April 2008   (final data collection date for primary outcome measure)
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 ]
Efficacy of Voriconazole as secondary prophylaxis on rate of occurrence of proven and probable invasive fungal infection up to 12 months FU
Complete list of historical versions of study NCT00143312 on ClinicalTrials.gov Archive Site
  • 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 ]
Efficacy at 6 months FU Efficacy until EOP visit Evaluate time to/of IFI Evaluate proportion of patients experiencing proven/probable recurrent/new IFI's Survival free at 6 and 12 months Safety and tolerability
Not Provided
Not Provided
 
Voriconazole for Secondary Prophylaxis of Invasive Fungal Infections in Patients With Allogeneic Stem Cell Transplants
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

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Prophylaxis Of Invasive Fungal Infections
Drug: voriconazole
Voriconazole is given to patients at least 48 hours after chemotherapy
Experimental: 1
Intervention: Drug: voriconazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   France,   United Kingdom,   Portugal,   Spain,   Sweden,   Switzerland,   Belgium
 
NCT00143312
A1501038
Yes
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
European Group for Blood and Marrow Transplantation
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP