Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual Primary Completion Date :||October 2009|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073618
|Study Director:||Pfizer CT.gov Call Center||Pfizer|