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Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01073618
First received: February 22, 2010
Last updated: May 31, 2012
Last verified: May 2012
History of Changes
Results First Received: August 20, 2010  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Serious Fungal Infections
Intervention: Drug: voriconazole IV

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were 692 participants enrolled in this study. Of these, 379 participants were treated with the IV formulation of Vfend only, and 313 participants were treated with Vfend IV and Vfend tablets sequentially or vice versa. These 313 participants are also included in study A1501068 (NCT01073631).

Reporting Groups
  Description
Vfend Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.

Participant Flow:   Overall Study
    Vfend  
STARTED     692  
COMPLETED     385  
NOT COMPLETED     307  
Death                 208  
Adverse Event                 19  
Unspecified                 80  



  Baseline Characteristics
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Reporting Groups
  Description
Vfend Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.

Baseline Measures
    Vfend  
Number of Participants  
[units: participants]
 		  692  
Age, Customized  
[units: participants]
 		 
<18 years     97  
Between 18 and 44 years     218  
Between 45 and 64 years     282  
>=65 years     95  
Gender  
[units: participants]
 		 
Female     275  
Male     417  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable   [ Time Frame: Baseline (Day 1) up to 2 years ]
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2.  Secondary:   Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable   [ Time Frame: Baseline (Day 1) up to 2 years ]
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  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.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01073618     History of Changes
Other Study ID Numbers: A1501067
Study First Received: February 22, 2010
Results First Received: August 20, 2010
Last Updated: May 31, 2012
Health Authority: Republic of Korea: Korean Food and Drug Administration