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

NCT ID: NCT00288197

Last Updated: 2008-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-06-30

Brief Summary

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

Detailed Description

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Conditions

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Invasive Fungal Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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voriconazole

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Guangzhou, Guangdong, China

Site Status

Pfizer Investigational Site

Wuhan, Hubei, China

Site Status

Pfizer Investigational Site

Wuhan, Hubei, China

Site Status

Pfizer Investigational Site

Beijing, , China

Site Status

Pfizer Investigational Site

Beijing, , China

Site Status

Pfizer Investigational Site

Hangzhou, , China

Site Status

Pfizer Investigational Site

Shanghai, , China

Site Status

Pfizer Investigational Site

Shanghai, , China

Site Status

Pfizer Investigational Site

Tianjin, , China

Site Status

Pfizer Investigational Site

Tianjin, , China

Site Status

Countries

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China

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1501066&StudyName=A%20Study%20To%20Assess%20The%20Efficacy%20And%20Safety%20Of%20Voriconazole%20In%20Chinese%20Patients%20With%20Serious%20Deep%20Tissue%20Fungal%20Infections

To obtain contact information for a study center near you, click here.

Other Identifiers

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A1501066

Identifier Type: -

Identifier Source: org_study_id