Back to resultsA Study To Assess The Efficacy And Safety Of Voriconazole In Chinese Patients With Serious Deep Tissue Fungal Infections
Primary Purpose
Invasive Fungal Infections
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
voriconazole
Sponsored by
About this trial
This is an interventional treatment trial for Invasive Fungal Infections
Eligibility Criteria
Inclusion Criteria: Subjects with proven or probable invasive fungal infections including subjects who have failed to respond to, or have an intolerance to other approved antifungal treatments and with approval for salvage treatment by Principal Investigator and Pfizer. Exclusion Criteria: Subjects who are showing continuing improvement with other antifungal agents, including amphotericin B, itraconazole, nystatin, fluconazole, flucytosine and miconazole. Subjects with an invasive fungal infection caused by a fungus (such as Mucor) that is not in the antifungal spectrum of voriconazole.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
Percent of subjects with a Global Efficacy assessment of either "cured" or "improved" by Week 6 visit.
Secondary Outcome Measures
Safety assessment during the study period (Adverse events observed between start of treatment and follow-up visit).
Percent of subjects with a Global Efficacy assessment of either "cured" or "improved" at the time when IV administration is completed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00288197
Brief Title
A Study To Assess The Efficacy And Safety Of Voriconazole In Chinese Patients With Serious Deep Tissue Fungal Infections
Official Title
An Open, Prospective, Uncontrolled, Multi-Center Study To Evaluate The Efficacy And Safety Of Voriconazole In Chinese Subjects With Proven Or Probable Serious Invasive Fungal Infections
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
To evaluate the efficacy and safety of voriconazole in Chinese patients with proven or probable deep tissue fungal infections.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Fungal Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
voriconazole
Primary Outcome Measure Information:
Title
Percent of subjects with a Global Efficacy assessment of either "cured" or "improved" by Week 6 visit.
Secondary Outcome Measure Information:
Title
Safety assessment during the study period (Adverse events observed between start of treatment and follow-up visit).
Title
Percent of subjects with a Global Efficacy assessment of either "cured" or "improved" at the time when IV administration is completed
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with proven or probable invasive fungal infections including subjects who have failed to respond to, or have an intolerance to other approved antifungal treatments and with approval for salvage treatment by Principal Investigator and Pfizer.
Exclusion Criteria:
Subjects who are showing continuing improvement with other antifungal agents, including amphotericin B, itraconazole, nystatin, fluconazole, flucytosine and miconazole.
Subjects with an invasive fungal infection caused by a fungus (such as Mucor) that is not in the antifungal spectrum of voriconazole.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Pfizer Investigational Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Pfizer Investigational Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Pfizer Investigational Site
City
Beijing
ZIP/Postal Code
100083
Country
China
Facility Name
Pfizer Investigational Site
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Pfizer Investigational Site
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
Pfizer Investigational Site
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Pfizer Investigational Site
City
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Pfizer Investigational Site
City
Tianjin
ZIP/Postal Code
300020
Country
China
Facility Name
Pfizer Investigational Site
City
Tianjin
ZIP/Postal Code
300052
Country
China
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1501066&StudyName=A%20Study%20To%20Assess%20The%20Efficacy%20And%20Safety%20Of%20Voriconazole%20In%20Chinese%20Patients%20With%20Serious%20Deep%20Tissue%20Fungal%20Infections
Description
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Learn more about this trial
A Study To Assess The Efficacy And Safety Of Voriconazole In Chinese Patients With Serious Deep Tissue Fungal Infections
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