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

June 10, 2008 updated by: Pfizer

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (ACTUAL)

June 1, 2007

Study Completion (ACTUAL)

June 1, 2007

Study Registration Dates

First Submitted

February 6, 2006

First Submitted That Met QC Criteria

February 6, 2006

First Posted (ESTIMATE)

February 7, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

June 12, 2008

Last Update Submitted That Met QC Criteria

June 10, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1501066

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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