A Study To Assess The Efficacy And Safety Of Voriconazole In Chinese Patients With Serious Deep Tissue Fungal Infections
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
1 other identifier
interventional
77
1 country
10
Brief Summary
To evaluate the efficacy and safety of voriconazole in Chinese patients with proven or probable deep tissue fungal infections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2006
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 6, 2006
CompletedFirst Posted
Study publicly available on registry
February 7, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedJune 12, 2008
June 1, 2008
1.4 years
February 6, 2006
June 10, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Percent of subjects with a Global Efficacy assessment of either "cured" or "improved" by Week 6 visit.
Secondary Outcomes (2)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (10)
Pfizer Investigational Site
Guangzhou, Guangdong, 510080, China
Pfizer Investigational Site
Wuhan, Hubei, 430022, China
Pfizer Investigational Site
Wuhan, Hubei, 430030, China
Pfizer Investigational Site
Beijing, 100083, China
Pfizer Investigational Site
Beijing, 100853, China
Pfizer Investigational Site
Hangzhou, 310003, China
Pfizer Investigational Site
Shanghai, 200040, China
Pfizer Investigational Site
Shanghai, 200080, China
Pfizer Investigational Site
Tianjin, 300020, China
Pfizer Investigational Site
Tianjin, 300052, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 6, 2006
First Posted
February 7, 2006
Study Start
January 1, 2006
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
June 12, 2008
Record last verified: 2008-06