Anidulafungin In Treatment Of Candidemia In Asian Subjects

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether or not the Investigational Study Drug anidulafungin is safe and effective in the treatment of a fungal infection, candidemia, in Asian subjects.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Anidulafungin; Echinocandins

Criteria

Inclusion Criteria:

• Subjects with at least one positive blood test for Candida pathogen from a blood sample taken within 96 hours prior to start of study treatment.

• Subjects with clinical evidence of candida infection within 48 hours prior to enrollment.

• Acute Physiology and Chronic Health Enquiry (APACHE) score less than or equal to 20.

Exclusion Criteria:

• Prior exposure to systemic antifungals for more than 48 hours.

• Subjects who had, at any time, previously received anidulafungin.

• Subjects with poor venous (vein) access that would inhibit the administration of the intravenous study drug or withdrawing of multiple blood samples.

• Life expectancy < 72 hours.