A Study To Assess The Efficacy And Safety Of Voriconazole In Chinese Patients With Serious Deep Tissue Fungal Infections
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Invasive Fungal Infections
Intervention: voriconazole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
To evaluate the efficacy and safety of voriconazole in Chinese patients with proven or
probable deep tissue fungal infections.
Clinical Details
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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percent of subjects with a Global Efficacy assessment of either "cured" or "improved" by Week 6 visit.
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Pfizer Investigational Site, Beijing 100853, China
Pfizer Investigational Site, Beijing 100083, China
Pfizer Investigational Site, Hangzhou 310003, China
Pfizer Investigational Site, Shanghai 200040, China
Pfizer Investigational Site, Shanghai 200080, China
Pfizer Investigational Site, Tianjin 300052, China
Pfizer Investigational Site, Tianjin 300020, China
Pfizer Investigational Site, Guangzhou, Guangdong 510080, China
Pfizer Investigational Site, Wuhan, Hubei 430022, China
Pfizer Investigational Site, Wuhan, Hubei 430030, China
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: January 2006
Last updated: June 10, 2008
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