Anidulafungin In Treatment Of Candidemia In Asian Subjects

Pfizer

Status and phase: Completed; Phase 3

Conditions: Candidemia

Treatments: Drug: Anidulafungin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00537329

PF-03910960

A8851016

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Open

Other group

Description:

This is an open-label, multi-center, non-comparative 12 week study evaluating the efficacy and safety of anidulafungin in subjects with candidemia.

Treatment:

Drug: Anidulafungin