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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00288197

Collaborator

(none)

Enrollment

Locations

Duration (Months)

7.7

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Jan 1, 2006

Actual Primary Completion Date :

Jun 1, 2007

Actual Study Completion Date :

Jun 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Guangzhou	Guangdong	China	510080
2	Pfizer Investigational Site	Wuhan	Hubei	China	430022
3	Pfizer Investigational Site	Wuhan	Hubei	China	430030
4	Pfizer Investigational Site	Beijing		China	100083
5	Pfizer Investigational Site	Beijing		China	100853
6	Pfizer Investigational Site	Hangzhou		China	310003
7	Pfizer Investigational Site	Shanghai		China	200040
8	Pfizer Investigational Site	Shanghai		China	200080
9	Pfizer Investigational Site	Tianjin		China	300020
10	Pfizer Investigational Site	Tianjin		China	300052