Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01073618
Previous Study | Return to List | Next Study

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
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date February 22, 2010
First Posted Date February 23, 2010
Results First Submitted Date August 20, 2010
Results First Posted Date September 16, 2010
Last Update Posted Date June 7, 2012
Study Start Date March 2006
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 31, 2012)
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).
Original Primary Outcome Measures
 (submitted: February 22, 2010)
  • Adverse events percentage. [ Time Frame: 28 days ]
  • Clinical improvement. [ Time Frame: 28 days ]
Change History Complete list of historical versions of study NCT01073618 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 31, 2012)
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.
Original Secondary Outcome Measures
 (submitted: February 22, 2010)
Mycologic response. [ Time Frame: 28 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV
Official Title Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV
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 Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who are indicated for VFEND according to drug package insert.
Condition Serious Fungal Infections
Intervention Drug: voriconazole IV
6 mg/kg iv q 12 hours (loading) then maintenance
Other Name: Vfend
Study Groups/Cohorts A.
Patients who are indicated for VFEND according to drug package insert.
Intervention: Drug: voriconazole IV
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 15, 2010)
692
Original Actual Enrollment
 (submitted: February 22, 2010)
696
Actual Study Completion Date October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Invasive aspergillosis and other serious fungal infections.

Exclusion Criteria:

  • N/A
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01073618
Other Study ID Numbers A1501067
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2012