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

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ClinicalTrials.gov Identifier: NCT00288197
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : June 12, 2008
Sponsor:
Information provided by:
Pfizer

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

Condition or disease Intervention/treatment Phase
Invasive Fungal Infections Drug: voriconazole Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine





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

Secondary Outcome Measures :
  1. Safety assessment during the study period (Adverse events observed between start of treatment and follow-up visit).
  2. 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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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288197


Locations
China, Guangdong
Pfizer Investigational Site
Guangzhou, Guangdong, China, 510080
China, Hubei
Pfizer Investigational Site
Wuhan, Hubei, China, 430022
Pfizer Investigational Site
Wuhan, Hubei, China, 430030
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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00288197     History of Changes
Other Study ID Numbers: A1501066
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: June 12, 2008
Last Verified: June 2008

Additional relevant MeSH terms:
Infection
Communicable Diseases
Mycoses
Invasive Fungal Infections
Voriconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors