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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00288197
First received: February 6, 2006
Last updated: June 10, 2008
Last verified: June 2008
History of Changes

February 6, 2006
June 10, 2008
January 2006
June 2007   (final data collection date for primary outcome measure)
Percent of subjects with a Global Efficacy assessment of either "cured" or "improved" by Week 6 visit.
Same as current
Complete list of historical versions of study NCT00288197 on ClinicalTrials.gov Archive Site
  • 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
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
Not Provided
Not Provided
 
A Study To Assess The Efficacy And Safety Of Voriconazole In Chinese Patients With Serious Deep Tissue Fungal Infections
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Invasive Fungal Infections
Drug: voriconazole
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
June 2007
June 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00288197
A1501066
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP