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

Completed

• Conditions: Serious Fungal Infections
• Interventions: Drug: voriconazole IV

• Registration Number: NCT01073618
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Study First Submitted: 2010-02-22
• Study First Submitted QC: 2010-02-22
• Study First Posted: 2010-02-23
• Results First Submitted: 2010-08-20
• Results First Submitted QC: 2010-08-20
• Results First Posted: 2010-09-16
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 692

Inclusion Criteria

• Invasive aspergillosis and other serious fungal infections.

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A.	voriconazole IV	Patients who are indicated for VFEND according to drug package insert.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable	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).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable	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.