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

Trial ID or NCT#

NCT00413218

Status

recruiting iconRECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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

Investigator(s)

Wes (Janice) Brown
Wes (Janice) Brown
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Infectious disease doctor
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

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Contact

Physician Referrals
650-723-0822