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OpenTrials
Completed

NCT Number: NCT01073618

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

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.

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Key information

Conditions

Serious Fungal Infections Bacterial Infections and Mycoses Infections Invasive Fungal Infections Mycoses

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Invasive aspergillosis and other serious fungal infections.

Exclusion criteria

  • N/A

Treatment and study plan

voriconazole IV

Drug

6 mg/kg iv q 12 hours (loading) then maintenance

Other names: Vfend

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Feb 23, 2010
Registry last updated
Jun 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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