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
  Purpose

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


Condition Intervention Phase
Invasive Fungal Infections
Drug: voriconazole
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Secondary Outcome 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

Enrollment: 77
Study Start Date: January 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288197

Locations
China, Guangdong
Pfizer Investigational Site
Guangzhou, Guangdong, China, 510080
China, Hubei
Pfizer Investigational Site
Wuhan, Hubei, China, 430030
Pfizer Investigational Site
Wuhan, Hubei, China, 430022
China
Pfizer Investigational Site
Beijing, China, 100083
Pfizer Investigational Site
Beijing, China, 100853
Pfizer Investigational Site
Hangzhou, China, 310003
Pfizer Investigational Site
Shanghai, China, 200040
Pfizer Investigational Site
Shanghai, China, 200080
Pfizer Investigational Site
Tianjin, China, 300020
Pfizer Investigational Site
Tianjin, China, 300052
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00288197     History of Changes
Other Study ID Numbers: A1501066
Study First Received: February 6, 2006
Last Updated: June 10, 2008
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Mycoses
Voriconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014