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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01073618
First received: February 22, 2010
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Serious Fungal Infections
Drug: voriconazole IV

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable [ Time Frame: Baseline (Day 1) up to 2 years ] [ Designated as safety issue: No ]
    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:
  • Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable [ Time Frame: Baseline (Day 1) up to 2 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 692
Study Start Date: March 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A.
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who are indicated for VFEND according to drug package insert.

Criteria

Inclusion Criteria:

  • Invasive aspergillosis and other serious fungal infections.

Exclusion Criteria:

  • N/A
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073618

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01073618     History of Changes
Other Study ID Numbers: A1501067
Study First Received: February 22, 2010
Results First Received: August 20, 2010
Last Updated: May 31, 2012
Health Authority: Republic of Korea: Korean Food and Drug Administration

Keywords provided by Pfizer:
voriconazole
Korea
invasive fungal infection

Additional relevant MeSH terms:
Infection
Mycoses
Voriconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014