Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV
|ClinicalTrials.gov Identifier: NCT01073618|
Recruitment Status : Completed
First Posted : February 23, 2010
Results First Posted : September 16, 2010
Last Update Posted : June 7, 2012
|Condition or disease||Intervention/treatment|
|Serious Fungal Infections||Drug: voriconazole IV|
|Study Type :||Observational|
|Actual Enrollment :||692 participants|
|Official Title:||Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV|
|Study Start Date :||March 2006|
|Primary Completion Date :||October 2009|
|Study Completion Date :||October 2009|
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
- Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable [ Time Frame: Baseline (Day 1) up to 2 years ]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).
- Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable [ Time Frame: Baseline (Day 1) up to 2 years ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073618
|Study Director:||Pfizer CT.gov Call Center||Pfizer|