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NCT00288197 Clinical Trial

A Study To Assess The Efficacy And Safety Of Voriconazole In Chinese Patients With Serious Deep Tissue Fungal Infections

Invasive Fungal Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00288197
Other study ID # A1501066
Secondary ID
Status Completed
Phase Phase 4
First received February 6, 2006
Last updated June 10, 2008
Start date January 2006
Est. completion date June 2007

Study information
Verified date June 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of voriconazole in Chinese patients with proven or probable deep tissue fungal infections.

Recruitment information / eligibility
Status Completed
Enrollment 77
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• voriconazole

Locations
Country Name City State
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Guangzhou Guangdong
China Pfizer Investigational Site Hangzhou
China Pfizer Investigational Site Shanghai
China Pfizer Investigational Site Shanghai
China Pfizer Investigational Site Tianjin
China Pfizer Investigational Site Tianjin
China Pfizer Investigational Site Wuhan Hubei
China Pfizer Investigational Site Wuhan Hubei

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent of subjects with a Global Efficacy assessment of either "cured" or "improved" by Week 6 visit.
Secondary Safety assessment during the study period (Adverse events observed between start of treatment and follow-up visit).
Secondary Percent of subjects with a Global Efficacy assessment of either "cured" or "improved" at the time when IV administration is completed
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