Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV
This study has been completed.
Information provided by (Responsible Party):
First received: February 22, 2010
Last updated: May 31, 2012
Last verified: May 2012
This is non-interventional study of voriconazole IV formulation in clinical use, which was mandated by the Korean government agency following the approval of Vfend in the Republic of Korea.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable [ Time Frame: Baseline (Day 1) up to 2 years ] [ Designated as safety issue: No ]Clinical response defined as: Cure=resolution of all baseline signs and symptoms of fungal infection(s); Improvement=lessening of baseline signs and symptoms or absence of one or more, but not all baseline findings; Failure=no improvement or deterioration of baseline condition; Unevaluable=incomplete therapy (efficacy could not be evaluated or discontinuation was not followed up).
Secondary Outcome Measures:
- Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable [ Time Frame: Baseline (Day 1) up to 2 years ] [ Designated as safety issue: No ]In case cultivation performed, cultivated strain before and after Vfend administration recorded, and the improvement of mycological outcomes after administration evaluated. Mycological response defined as: Eradication=absence of signs and symptoms of fungal infection; Persistence=(no eradication) presence of fungal infection; Superinfection=existence of different strains from strains separated prior to study medication; Not evaluable=a follow-up mycological cultivation is not performed.
|Study Start Date:||March 2006|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Patients who are indicated for VFEND according to drug package insert.
Drug: voriconazole IV
6 mg/kg iv q 12 hours (loading) then maintenance
Other Name: Vfend
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