A Study To Assess The Efficacy And Safety Of Voriconazole In Chinese Patients With Serious Deep Tissue Fungal Infections
Phase 4
Completed
- Conditions
- Invasive Fungal Infections
- Registration Number
- NCT00288197
- Lead Sponsor
- Pfizer
- Brief Summary
To evaluate the efficacy and safety of voriconazole in Chinese patients with proven or probable deep tissue fungal infections.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 77
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Percent of subjects with a Global Efficacy assessment of either "cured" or "improved" by Week 6 visit.
- Secondary Outcome Measures
Name Time Method Percent of subjects with a Global Efficacy assessment of either "cured" or "improved" at the time when IV administration is completed Safety assessment during the study period (Adverse events observed between start of treatment and follow-up visit).
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇨🇳Tianjin, China