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

Serious Fungal Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01073618
• Other study ID #: A1501067
• Status: Completed
• Phase: N/A
• First received: February 22, 2010
• Last updated: May 31, 2012
• Start date: March 2006
• Est. completion date: October 2009

Study information

• Verified date: May 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Republic of Korea: Korean Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 692
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Invasive aspergillosis and other serious fungal infections.

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mycoses
• Serious Fungal Infections

Intervention

Drug:
• voriconazole IV
6 mg/kg iv q 12 hours (loading) then maintenance

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable	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).	Baseline (Day 1) up to 2 years	No
Secondary	Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable	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.	Baseline (Day 1) up to 2 years	No

External Links

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