NCT00288197
Completed
Phase 4
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
ConditionsInvasive Fungal Infections
Drugsvoriconazole
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- Percent of subjects with a Global Efficacy assessment of either "cured" or "improved" by Week 6 visit.
Overview
Brief Summary
To evaluate the efficacy and safety of voriconazole in Chinese patients with proven or probable deep tissue fungal infections.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Percent of subjects with a Global Efficacy assessment of either "cured" or "improved" by Week 6 visit.
Secondary Outcomes
- 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
Investigators
Study Sites (1)
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