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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Invasive Fungal Infections

Intervention: voriconazole (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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

Clinical Details

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

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

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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.

Locations and Contacts

Pfizer Investigational Site, Beijing 100853, China

Pfizer Investigational Site, Beijing 100083, China

Pfizer Investigational Site, Hangzhou 310003, China

Pfizer Investigational Site, Shanghai 200040, China

Pfizer Investigational Site, Shanghai 200080, China

Pfizer Investigational Site, Tianjin 300052, China

Pfizer Investigational Site, Tianjin 300020, China

Pfizer Investigational Site, Guangzhou, Guangdong 510080, China

Pfizer Investigational Site, Wuhan, Hubei 430022, China

Pfizer Investigational Site, Wuhan, Hubei 430030, China

Additional Information

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

Starting date: January 2006
Last updated: June 10, 2008

Page last updated: August 23, 2015

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