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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
History of Changes
Results First Received: April 2, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Prophylaxis Of Invasive Fungal Infections
Intervention: Drug: voriconazole

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects with proven or probable Invasive Fungal Infection (IFI) in the previous 12 months, who were receiving an allogeneic Stem Cell Transplant (SCT) for any hematologic disease, were enrolled into the study if all other inclusion/exclusion criteria were met.

Reporting Groups
  Description
Voriconazole All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.

Participant Flow:   Overall Study
    Voriconazole  
STARTED     45  
COMPLETED     29  
NOT COMPLETED     16  
Death                 11  
Adverse Event                 2  
Lost to Follow-up                 1  
Unknown                 1  
Withdrawal by Subject                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Voriconazole All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.

Baseline Measures
    Voriconazole  
Number of Participants  
[units: participants]
 		  45  
Age  
[units: years]
Mean ± Standard Deviation 		  48.4  ± 14.1  
Gender  
[units: participants]
 		 
Female     17  
Male     28  



  Outcome Measures
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1.  Primary:   Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit   [ Time Frame: 12 months ]
  Show Outcome Measure 1

2.  Secondary:   Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit   [ Time Frame: 6 months ]
  Show Outcome Measure 2

3.  Secondary:   Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit   [ Time Frame: 150 days ]
  Show Outcome Measure 3

4.  Secondary:   Time to Occurrence of Proven or Probable Invasive Fungal Infection (IFI)   [ Time Frame: 12 months ]
  Show Outcome Measure 4

5.  Secondary:   Time to Occurrence of Proven or Probable New (New Pathogen) Invasive Fungal Infection (IFI)   [ Time Frame: 12 months ]
  Show Outcome Measure 5

6.  Secondary:   Time to Occurrence of Proven or Probable Recurrent Invasive Fungal Infection (IFI) (Same Pathogen as Previous Baseline IFI)   [ Time Frame: 12 months ]
  Show Outcome Measure 6

7.  Secondary:   Survival Without Proven or Probable Invasive Fungal Infection (IFI)   [ Time Frame: 6 months, 12 months ]
  Show Outcome Measure 7


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


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)