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”

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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2007

Intervention(s) in this Clinical Trial

• Drug: voriconazole

Primary Measures

• Percent of subjects with a Global Efficacy assessment of either "cured" or "improved" by Week 6 visit.

Secondary Measures

• 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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00288197

Study ID Number: A1501066

ClinicalTrials.gov Identifier: NCT00288197

Health Authority: China: State Food and Drug Administration

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Link to ClinicalStudyResults.org Posting