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Trial record 1 of 1 for:    NCT00143312
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Voriconazole for Secondary Prophylaxis of Invasive Fungal Infections in Patients With Allogeneic Stem Cell Transplants (VOSIFI)

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ClinicalTrials.gov Identifier: NCT00143312
Recruitment Status : Completed
First Posted : September 2, 2005
Results First Posted : June 1, 2009
Last Update Posted : October 6, 2009
Sponsor:
Collaborator:
European Group for Blood and Marrow Transplantation
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE August 31, 2005
First Posted Date  ICMJE September 2, 2005
Results First Submitted Date  ICMJE April 2, 2009
Results First Posted Date  ICMJE June 1, 2009
Last Update Posted Date October 6, 2009
Study Start Date  ICMJE February 2005
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2009)
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2005)
Efficacy of Voriconazole as secondary prophylaxis on rate of occurrence of proven and probable invasive fungal infection up to 12 months FU
Change History Complete list of historical versions of study NCT00143312 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2009)
  • Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit [ Time Frame: 6 months ]
  • Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit [ Time Frame: 150 days ]
  • Time to Occurrence of Proven or Probable Invasive Fungal Infection (IFI) [ Time Frame: 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 Recurrent Invasive Fungal Infection (IFI) (Same Pathogen as Previous Baseline IFI) [ Time Frame: 12 months ]
  • Survival Without Proven or Probable Invasive Fungal Infection (IFI) [ Time Frame: 6 months, 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2005)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Voriconazole for Secondary Prophylaxis of Invasive Fungal Infections in Patients With Allogeneic Stem Cell Transplants
Official Title  ICMJE 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).
Brief Summary To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell transplants
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Prophylaxis Of Invasive Fungal Infections
Intervention  ICMJE Drug: voriconazole
Voriconazole is given to patients at least 48 hours after chemotherapy
Study Arms  ICMJE Experimental: 1
Intervention: Drug: voriconazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2009)
45
Original Enrollment  ICMJE
 (submitted: September 1, 2005)
75
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Germany,   Portugal,   Spain,   Sweden,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00143312
Other Study ID Numbers  ICMJE A1501038
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE European Group for Blood and Marrow Transplantation
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2009

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