A Study To Assess The Efficacy And Safety Of Voriconazole In Chinese Patients With Serious Deep Tissue Fungal Infections
To evaluate the efficacy and safety of voriconazole in Chinese patients with proven or probable deep tissue fungal infections...
Brief Summary
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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: June 2007
Intervention(s) in this Clinical Trial
- Drug: voriconazole
Outcome Measures for this Clinical Trial
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
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Pfizer Industry
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00288197
