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Completed

NCT Number: NCT00288197

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

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

Completed

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Key information

Conditions

Invasive Fungal Infections Bacterial Infections and Mycoses Infections Mycoses

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Voriconazole

Drug

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 7, 2006
Registry last updated
Jun 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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