Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections

Recruiting

Trial ID: NCT00413218

Purpose

The purpose of the study is to compare the safety and efficacy of isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.

Official Title

A Phase III, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 Versus a Caspofungin Followed by Voriconazole Regimen in the Treatment of Candidemia and Other Invasive Candida Infections

Stanford Investigator(s)

Eligibility


Inclusion Criteria:

   - Patients with candidemia or with an invasive Candida infection

   - Presence of fever, hypothermia or other appropriate local sign of infection

   - Female patients must be non-lactating and at no risk of pregnancy

Exclusion Criteria:

   - Patients with a sole diagnosis of mucocutaneous candidiasis, i.e. oropharyngeal,
   esophageal or genital candidiasis; or candidal lower urinary tract infection or
   Candida isolated solely from respiratory tract specimens

   - Patients with candidemia who failed a previous antifungal therapy for the same
   infection

   - Patients previously enrolled in a phase III study with isavuconazole

   - Patients with a body weight <40kg

Intervention(s):

drug: Isavuconazole

drug: Caspofungin

drug: Voriconazole

Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Physician Referrals
650-723-0822

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