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

Completed · Phase 3

Conditions studied: Candidiasis, Invasive, Candidemia, Mycoses

In brief

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.

Key facts

Study ID

NCT00413218

Run by

Astellas Pharma Inc

People needed

450

Starts

2007-03-08

Expected to finish

2015-03-03

Last updated by the study team

2024-12-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Somero Research Corporation — Palm Desert, California, United States
• University of California Davis Health System — Sacramento, California, United States
• University of California at San Francisco — San Francisco, California, United States
• Idaho Falls Infectious Diseases PLLC — Idaho Falls, Idaho, United States
• Loyola University Hospital — Maywood, Illinois, United States
• Springfield Clinic LLP — Springfield, Illinois, United States
• Infectious Disease of Indiana — Indianapolis, Indiana, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• University of Maryland School of Medicine — Baltimore, Maryland, United States
• UMASS Memorial Medical Center — Worcester, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Mercury Street Medical Group — Butte, Montana, United States
• Jersey Shore University Medical Center — Neptune City, New Jersey, United States
• New York Presbyterian Hospital — New York, New York, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Regional Infection Diseases Infusion Center Inc. — Lima, Ohio, United States
• Temple University Health Sciences — Philadelphia, Pennsylvania, United States
• Hospital Britanico de Buenos Aires — Capital Federal, Argentina
• Hospital General de Agudos Dr. Carlos G. Durand — Capital Federal, Argentina
• Hospital Italiano de Buenos Aires — Ciudad Autonoma, Argentina
• Instituto Medico Especializado Alexander Fleming — Ciudad Autonoma, Argentina
• Hospital General de Agudos Dr. Cosme Argerich — La Boca, Argentina
• Fremantle Hospital — Fremantle, Australia
• Mater Adult Hospital — South Brisbane, Australia
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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