Invasive Fungal Infections
Conditions
Brief summary
To evaluate the efficacy and safety of voriconazole in Chinese patients with proven or probable deep tissue fungal infections.
Interventions
DRUGvoriconazole
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of subjects with a Global Efficacy assessment of either cured or improved by Week 6 visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
China
Outcome results
None listed