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

• Status: Completed
• Trial end date: 2015-03-03
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Basilea Pharmaceutica
• Treatments: Caspofungin; Echinocandins; Isavuconazole; Voriconazole

Criteria

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